Leaders in Frequency Specific Microcurrent Education

GENERAL

Micro current is current in millionths of an ampere. An ampere is a measure of the movement of electrons past a point. Microamperage current is the same kind of current your body produces on its own within each cell. This is current in millionths of an amp. It is very small; there is not enough current to stimulate sensory nerves so the current flow cannot be felt. You can tell it is running by watching the conductance meter on the machine.
Anyone who has enough medical background to understand and benefit from the course can attend. In order to practice FSM and purchase and use the equipment on patients, they must have a license that allows them to use electrical stimulation or does not restrict them from using electrical stimulation on patients or must work for someone who has such a license. The course is geared toward medical, chiropractic, osteopathic and naturopathic physicians, acupuncturists and physical therapists and the assistants who function in all of these clinical settings.

I work with FSM because it brings relief to so many patients for so many conditions. It is low risk, non-invasive and incredibly effective. Every practice that uses FSM sees an increase in patient flow as one patient who has been helped refers another. Patients who return to their referring doctor with dramatic improvements often generate referrals of new patients from that provider to the FSM practitioner. Chronic patients are helped and move on to infrequent care leaving room for new patients. Almost every practice that has used FSM sees an increase in practice income because of these patient and professional referrals. I started teaching FSM to see if it was reproducible. I keep teaching FSM because it would be immoral not to. Every day FSM creates effects and provides relief that is simply not possible with any other modality or any other known treatment. Every day FSM practitioners report results produced with FSM to change patient’s lives. It is an awesome experience.

The personal reward and satisfaction of using a modality that can provide such profound relief make FSM practitioners a passionate and happy group. As a group FSM practitioners need to be brighter than the average clinician because the diagnosis has to be correct. As a group, they tend to see more and more complicated patients because they can help. As a group, need to have a practice model that allows for 20 to 40-minute appointment slots. FSM is not suited to a 5-minute chiropractic model or a 7-minute medical model. The practitioner can use clinical assistants to provide the care once the diagnosis and treatment plan have been created by the trained clinician.

FSM started with an observation of a clinical effect. It has continued to prove these effects to be consistent, reproducible, measurable and predictable. FSM practitioners love having a tool that allows them to help patients. You work with FSM because you love it.

Frequency Specific Microcurrent is a new system of treatment using microamperage current and the resonance effects of frequencies on tissues and conditions to create beneficial changes in symptoms and health. Frequency Specific Microcurrent (FSM) seminars teach frequency protocols and discuss the observed effects of frequencies and biological resonance on physical tissue based on clinical observations and research. FSM seminars are NOT about the use of microcurrent or microcurrent devices.

These are answers to some of the most common questions.

Frequency Specific Microcurrent (FSM) has been taught in seminars since 1997. FSM is now taught as a three day course available for 24 hours of continuing education credit for many disciplines in most states and it is available on DVD. Practitioners are advised to check with their board if continuing education course credit is important to them. The course has been taught to chiropractic, naturopathic, osteopathic and medical physicians, physical therapists, acupuncturists, occupational therapists and massage therapists and the assistants who function in their practices.

The course includes lecture time and 6 hours of hands-on practice time. The lecture includes the frequencies, frequency protocols, research data and conceptual framework within which the observed and documented FSM effects can be used and explained. The conceptual framework comes from physics, biophysics and thermodynamics but is structured in lay terms. The frequencies and treatment protocols for myofascial pain, disc, facet and nerve pain are taught on the first day. The protocols and frequencies for treating new injuries, the nervous system and visceral conditions and emotional issues are taught on the second and third days.

FSM effects are very specific to the condition and require an accurate clinical diagnosis to be optimally effective. The course includes refreshers for the accurate diagnosis of discogenic and facet generated pain, neuropathic pain and ligamentous laxity, myofascial trigger points caused by overuse, joint dysfunction and visceral referral.

The 6 hours of practical sessions include how to use the protocols to treat pain complaints in various body parts. The treatment method and application is different than any other way of treating muscular pain for example because the contacts are placed in such a way as to allow frequencies and current to flow through the tissue being treated and pressure is used only to move the tissue while the frequency is breaking up the scar tissue.

There are at least 8 FSM Core seminars taught each year in every region of the US and abroad by Dr. McMakin. The FSM Core seminar is also available via DVD with practical hands-on instruction provided by a certified FSM practicum instructor. For those in Ireland and the U.K. Denise Curtis MSc, PT teaches an FSM Core seminar at the National Training Centre (ntc.ie) in Dublin, Ireland that is held over two weekends.

During the practicum portions of the FSM Core seminar, there is generally at least one instructor for every 8-10 students. The Core seminar is available on DVD and practitioners can learn how to use FSM by reading the Frequency Specific Microcurrent in Pain Management text book.  DVD learners can make arrangements with a trained FSM practicum instructor to be trained in the manual techniques and protocols for FSM in physical medicine in a private or small setting tutorial.

Once a year, there is a two day 16 hour FSM advanced course that provides the complete list of frequencies and protocols not taught in the Core seminar. In the afternoon there are 90-minute advanced in-depth workshops presented by various expert practitioner faculty. Every other year on this same weekend, there is a two-day International Symposium with guest lecturers and presentations by practitioners sharing case reports and research findings and workshops for both diagnosis and treatment. There is a two-day instructor training and certification for people wishing to be considered as instructors for the practical sessions.

Frequency protocols are sequences of frequencies observed to have a certain clinical effect in various conditions as determined in Dr. McMakin’s practice and by input from other FSM practitioners. The sequences of frequencies are taught in the FSM seminars and the students are provided with a summary sheet of frequencies and the most common protocols for conditions found to be successfully treated. The most commonly effective and useful protocols have been pre-programmed into an automated microcurrent unit that sequences through frequencies automatically for unattended in office care. There are no claims made for the effectiveness of the frequency protocols. They are to be used so that the effects can be observed in clinical practice.

For example the question, “Does this frequency combination reduce inflammation in the liver?” the only truly honest answer is, “That has not been determined with certainty.” It can only be said that when these particular frequency combinations are applied to the right upper quadrant of the abdomen for a period of 30 to 60 minutes the liver becomes non-tender instead of tender and seriously elevated liver enzymes have been reduced into the normal range within hours instead of days or weeks. This phenomenon has been observed in multiple patients, treated by different physicians in different areas. It is now thought to be reproducible as demonstrated by objective measurement of liver enzymes. More study is required before any definite statement can be made.

EQUIPMENT

The manufacturers and distributors of the equipment used in the FSM courses are completely separate from FSM and are not involved in Frequency Specific Seminars or in the teaching of uses of frequencies. The frequencies have to be delivered by some sort of electromagnetic device that supplies current. These devices are categorized as TENS devices and as such are only approved for and used in the treatment of pain. Most of the applications of frequencies are for pain which is consistent with the approved use of the devices. But the effects of biological resonance and frequencies have nothing to do with the devices or their approved uses.

Ultra sound creates ultrasonic vibrations and creates heat by vibrating the water molecules in the tissue. It does not provide current nor does it change ATP status. It provides beneficial results by these mechanisms but it is just completely different than microcurrent.

Microcurrent is approved in the category of TENS devices by the FDA. TENS devices deliver milliamp current and block pain messages that are tying to get up the spine to the brain. Microcurrent delivers subsensory microamperage current, 1000 times less than milli-amperage current, which has been shown in published studies to increase ATP production in tissues.

So the question comes up, what are the difference between FSM frequencies and rife frequencies?

A lot of people have heard about Royal Raymond rife who used frequencies to treat cancer in the early 1900s. I think it was in the 1930s or so. He used a light microscope and his frequencies were light frequencies and they were between 8000 and 16,000 Hertz. He could tune the light on this microscope and watch it. When he got to a certain light frequency, it would literally cause this bacteria, or cancer cell, or virus to just blow up.

So his frequencies are all in the light frequency range. 8000 to 16,000 Hertz. He had hundreds of cancer terminal cancer patients that he had cured with his frequency therapy using these light frequencies. And unfortunately for us, the FDA and the American Medical Association decided they needed to shut him down. They raided his lab one morning, destroyed his equipment, confiscated all his records, and that was the end of that.

The rife devices that are out on the markets. Some of them actually have had access to his list of frequencies. But those frequencies are all between about 8,000 and 16,000 hertz because they were light frequencies when those frequencies are talked about as electrical pulses Rife didn’t use them that way. He used them as light frequencies. So the basic difference between rife and FSM is his frequencies or higher. All of the FSM frequencies are below a thousand hertz. I think 988 is the highest frequency we use. And then they run the whole range, one hertz, three hertz, two Hertz, clear up to 970 hertz to 988 hertz. And we use two channels. So when you use two channels, you have a frequency on channel A and a frequency on channel B and in the treatment area where those two frequencies cross the frequencies mix.

And so you have the frequency from Channel A and the frequency from B, you have the sum of the two frequencies, and you have the difference between the two frequencies. And quite honestly, we don’t know which part of that field has the therapeutic effect. So theoretically some of those frequency combinations; so if you’re treating 970 hertz on channel A and 783 hertz on channel B, we can get a combination beat frequency in the middle that above a thousand hertz. But the frequency’s themselves are all below a thousand hertz.

The other big difference is that we don’t treat cancer with frequency specific microcurrent for a number of reasons. Number one is that I don’t want to have happen to me what happened to Rife. That’s probably the first thing. But the second thing is that cancer serious. If I use a frequency and correctly and I make your pain worse, it’s just pain. But if we do something inadvertently through ignorance that accidentally make your cancer worse, I don’t have a way to help you get on top of it. So we don’t treat cancer. We can treat the side effects of cancer therapy. There are frequencies that take away the nausea from chemotherapy. We can treat, radiation burns from patients that are getting radiation therapy, and we treat very effectively the scar tissue from radiation therapy. So that’s the biggest difference between FSM and rife is just the range of the frequencies and what we treat with them.

Microcurrent provides electrons and in published studies increases ATP production in cells. Lasers provide photons. I am not aware of any research suggesting that laser treatment increases ATP production. Lasers oscillate at set frequencies and provide beneficial results but usually only provide one frequency at a time instead of the dual frequencies used in FSM treatment. Lasers provide whatever benefits they provide by some other method than frequency specific resonance and ATP enhancement.

The machines, approved as TENS devices, can only provide symptomatic relief of pain. The current can increase ATP production as shown in the peer reviewed article published by Ngok Cheng in 1982.

EFFECTIVENESS

Frequencies are pulses per second measured in hertz. They can be sound waves or electronic pulses. The frequencies used in FSM are electromagnetic pulses used on two channels firing at the same time. The frequencies are delivered using a ramped square wave that includes high frequency harmonics to create the square wave. The makes the frequencies more accurately pulses rather than the pure frequencies achieved with a sine wave generator. Most microcurrent devices use square wave pulses because they have been observed to be more effective clinically.

The frequency thought to address or neutralize the condition is put on channel A. The frequency thought to address the tissue is put on channel B. The frequencies used in FSM are all less than 1000 Hz. There are frequencies from the list alleged to address over 200 conditions from very common conditions like “inflammation”, “scar tissue”, “mineral deposits” and “toxicity” to very unusual and hard to document conditions like “polio virus”, “trauma” and congestion. There can be no claims made for the effects of the frequencies until research has documented their effects. All that can be said is that use of this or that frequency had this observed effect in this patient with a certain condition.

There are a few frequencies that are used as A/B pairs. A is not a condition, B is not a tissue but the combination of the two frequencies appears to have a therapeutic effect. There is one such frequency combination that takes away shingles pain. When this combination is used before the blisters break out for an hour a day for three days the pain is gone in 20 minutes and the blisters never break out. When this combination is used for two hours on active shingles, after the blisters appear, it eliminates the pain and shortens the course from the normal 6 weeks to four to five days. The pain never returns. Shingles is the only thing this frequency combination is good for and, so far, there has not been a patient who did not respond in an expected way.

Dr. McMakin didn’t develop the frequencies. The frequencies were developed between 1910 and 1934 by medical and osteopathic physicians using an entirely different machine and system of treatment. The frequencies are used clinically; the effects are documented in chart notes and serve as a basis for the development of protocols that appear to be effective for different clinical conditions. The protocols are taught during FSM seminars and then it is determined if the effects are reproducible based on feedback from practitioners. There are four peer-reviewed published papers documenting the effects in the treatment of myofascial pain from trigger points, neuropathic pain from fibromyalgia associated with spine trauma and delayed onset muscle soreness.

Patients who are dehydrated cannot benefit from FSM. It has been observed that patients who are dehydrated. Athletes with large muscle mass and inadequate water intake and patients over 70 who are chronically dehydrated have the most problems. Every patient is advised to drink at least one quart of water in the one hour preceding treatment. Patients who are chronically dehydrated may need more water over several days prior to their treatments.

No technique is 100% effective and FSM is no exception. The effectiveness of FSM depends almost entirely on an accurate diagnosis. Shoulder pain can come from muscles, tendons, bursa, discs, nerves or joints. FSM will treat all of these pain generators effectively. But, if you are treating for muscle and the shoulder pain is from nerves or the bursa you may change the muscle but you won’t change the patient’s pain since it is not coming from the muscle. This analogy applies to every condition.

The frequencies appear to change a variety of conditions and tissues and change pain and function in a large number of clinical conditions. FSM is especially effective at treating nerve and muscle pain, inflammation and scar tissue. There is a kind of fibromyalgia associated with spine trauma that is particularly painful and difficult to treat even with narcotics. There is one frequency combination, and only one frequency combination, that has been observed to eliminate pain in patients with this condition. Shingles responds very well to only one frequency combination that eliminates the pain in 20 minutes and causes the lesions to dry up and disappear in approximately two to three days. There is one frequency combination that so far has been 100% effective in eliminating kidney stone pain. This frequency combination does nothing to remove the stone; it only eliminates the pain. The frequencies have created observed effects in asthma, liver dysfunction (reducing elevated liver enzymes), irritable bowel and many other conditions. It has been observed that patients who are treated within four hours of a new injury including auto accidents and surgeries have much reduced pain and a greatly accelerated healing process.

Frequency Specific Seminars makes no claims about the use of frequencies in the diagnosis and treatment of any condition. The frequencies appear to have beneficial affects when used in a clinical setting as an adjunct to appropriate medical diagnosis and treatment. More research is needed to document specific effects.

There are no guarantees that any protocol is going to be effective in any given patient on any given condition. In general, the frequencies either work or don’t work and if they don’t work they simply have no effect. In the seminars, physicians are advised to use good judgment and use FSM as an adjunct to appropriate medical diagnosis and treatment. As long as appropriate proven therapies are not delayed or withheld, FSM can be very helpful. Every practitioner is trained in the concept that FSM is to be used as an adjunct to therapeutics appropriate to their discipline for the patient after proper diagnosis. The FSM motto is “Can’t hurt; might help.”

It is NOT recommended that the frequencies be used to treat cancer. The condition is too serious and too complicated to be addressed with this technique. Dr. Arlene Lennox of Fermi Labs in Chicago published a paper showing that patients treated for scar tissue following neutron therapy for cancer that still had active tumor during the microcurrent treatment with Acuscope device had no increase in tumor growth and actually tolerated radiation therapy with fewer side effects.

ABOUT US

In 1982 Ngok Cheng published, “The Effect of Electric Currents on ATP Generation, Protein Synthesis and Membrane Transport in Rat Skin in Clinical Orthopedics” (volume 171: pages 264-272). This study showed that microcurrent increased ATP production in rat skin by 500%. ATP is the chemical that the body uses for energy. The current also increased amino acid transport into the cell by 70% and waste product removal. The implications for human healing and repair are obvious. ATP production was increased as long as the current was below 500 microamps. When the authors increased the current to 1000 micro amps, or one milliamp, a current range delivered by TENS devices and other types of electrical stimulation therapies, the ATP production was actually reduced.

Our goal is to treat every patient in pain who wants to be helped by training practitioners who can treat them. And to teach, research, publish and promote FSM in such a way that it survives and thrives.

“Frequency Specific Microcurrent
Changing medicine one patient at a time
Changing patients’ lives one doctor at a time”

HISTORY OF FSM

In the early 1900’s, before 1934, medical physicians and osteopaths were using electromagnetic therapy devices and frequencies to treat patients. The equipment delivered frequencies on either one or two channels. When two channels were used one channel delivered a frequency thought to address a specific tissue; and the other channel delivered one that was thought to neutralize a specific condition or pathology. There were thousands of physicians using these therapies to treat patients and doing research and sharing the effects of frequencies in articles and books. The Electromedical Society and its journal, Electromedical Digest were founded by Dr. Albert Abrams a medical physician in San Francisco.

The equipment used in the 1920’s was not battery operated DC microcurrent. The old devices plugged into the wall and used wall current which at that time was more likely to be direct current than AC. AC current did not come into universal use until a number of years later.

In 1934, the American Medical Association in the person of Maurice Fishbein declared that electromagnetic therapies were “unscientific” and that drugs and surgery were the future of medicine and that any physician who used electromagnetic therapies would lose their license to practice medicine, which at that time was granted by the AMA not the government. Electromagnetic treatments and research gradually declined. The equipment stopped being manufactured and by the mid-1950’s was removed from the market by the FDA.

The frequencies were still available in books and articles and in the manuals that came with the old devices.

In 1994, Carolyn McMakin, DC began using frequencies obtained from Dr. Harry Van Gelder, a retired osteopath on her family and on volunteer patients and friends. Once it was determined that a frequency producing no benefit also produced no harm, they were used on Dr. McMakin’s chiropractic patients to see if any positive effects could be observed. The results were immediate and fascinating.

The frequencies appeared to do exactly what they were alleged to do as described on the list. The frequency said to “decrease inflammation”, reduced redness and swelling but had no other effect. The frequency to “reduce scar tissue” increased range of motion and softened tissue but had no effect on inflammation, redness or swelling. The frequency to stop bleeding reduced bleeding in the menses and reduced or eliminated bruising if used immediately after an injury or surgery but had no effect on inflammation, scar tissue or range of motion. Eventually frequencies were added from the writings of Dr. Albert Abrams and from a list obtained from Dr. McWilliams.

After treating patients and observing these effects for over a year Dr. McMakin first taught the technique in January 1997 to determine whether the effects were reproducible. Did the technique actually have a real effect or was this some apparent effect produced by the patient’s mind or reaction to something else in the clinic environment? By June of 1997 it was apparent that students were achieving the same results as Dr. McMakin especially in the treatment of myofascial pain from trigger points. In 1998, frequency combinations were first used to successfully treat nerve pain such as sciatica caused by disc injuries. Only one frequency combination was effective in reducing nerve pain. In 1999 one frequency combination was found to eliminate the full body pain associated with fibromyalgia caused by spine trauma. Those cases were published in 2005 in a peer-reviewed article titled, “Cytokine changes in fibromyalgia associated with cervical trauma”.

Classes continue to be taught around the US and in Ireland so that practitioners can bring these effects and the relief they create to patients.

The frequency thought to “reduce inflammation in the immune system” was studied in an animal research laboratory at University of Sydney in Australia by Dr. Vivienne Reeve. Arachadonic acid was painted on the ears of hairless mice. Arachadonic acid causes inflammation mediated by lipoxygenase prostaglandin pathways and causes swelling. This animal model is an accepted way to study inflammation and has been used to study virtually every anti-inflammatory drug or therapy. The frequency combination reduced swelling by 62% in four minutes in every animal tested with everyone in the lab blinded and as tested against a placebo frequency. Prescription and non-prescription drugs tested in this animal model reduced swelling by 45%. Placebo frequency had no effect on swelling. None of the three other frequency combinations tested in this animal model reduced inflammation at all. The frequency response was time-dependent. 50% of the effect was present at 2 minutes, 100% of the effect was present at 4 minutes and further time spent on the frequency had no additional effect. This is the only frequency combination that has been studied in an animal model but the effects and the implications are important.

In an additional animal trial, myristeal stearate was painted on the mouse’s ears creating inflammation and swelling in a COX (cycloxygenase) mediated inflammatory pathway. The frequency to “reduce inflammation in the skin” had no effect on swelling at all. It was equivalent to placebo. The frequency combination thought to “reduce inflammation in the immune system” reduced COX mediated inflammation by 30% in a four-minute time-dependent response as compared to placebo. This reduction in swelling is equivalent to that created by the prescription injectable drug Toridol when it was tested in this animal model.

Sunburn creates swelling and inflammation. The mice were exposed to UV light sufficient to create sunburn and swelling. One group was not treated, one group was treated immediately and one group was treated at 2 hours after exposure. The untreated group had the expected swelling. The group treated immediately had a slight but not statistically significant reduction in swelling when measured at 21, 23, 25 and 27 hours after exposure. The group treated at 2 hours had a statistically significant reduction in swelling (p>.01).

One way of measuring immune system response is to expose it to a chemical to which it should normally develop an allergic reaction and then treat the system in some way and see if the immune response upon re-exposure is the same or different after the intervention. Sunburn suppresses immune system allergy responses. Mice exposed to a sensitizing chemical, oxazalone, normally swell by 30 units of measurement when re-exposed to the chemical two weeks after the first application. Mice that are sunburned but not treated swell only 11 units indicating an immune response suppression of 63.4%. Mice that were treated with FSM at 2 hours, with the best reduction in sunburn swelling, had 13 units of swelling upon second exposure to oxazalone indicating immune suppression of 57.48%. Mice that were treated immediately with FSM, who had only a slight reduction in burn swelling, had 21 units of swelling when re-exposed to oxazalone two weeks after the burn and FSM treatment. This represents a reduction of immune system suppression from 63.4% to 31.05%. Of all of the FSM human and animal data this is the most impressive and fascinating. A single four minute exposure to a frequency combination caused a permanent change in immune system function as measured two weeks after the treatment. This experiment has not been repeated but Dr. Reeve is the top in her field and certifies that the research was carried out to the highest laboratory standards of animal testing.

Microcurrent was first used in the 1980s by physicians in Europe and the US for stimulating bone repair in non-union fractures. There are numerous studies published on the effects of single channel microcurrent showing that it increases the rate of healing in wounds and fractures. There is one study showing that microamperage current between 10 and 500 micro amps increases ATP (cellular energy) production by 500% in rat skin. Current levels between 500 and 1000 micro amps caused energy production to level off. Current levels above 1000 micro amps caused ATP production to decline.

There are a number of devices on the market that can deliver micro amperage current. All of the research and papers published on Frequency Specific Microcurrent (FSM) have been done using a device manufactured by Precision Microcurrent Inc. But any microcurrent device with two independent channels that provide three-digit specific frequencies such as 284 Hz (rather than 280 Hz) on each channel, using a ramped square wave and either polarized or alternating DC current can be used.

Frequency Specific Microcurrent (FSM) seminars teach frequency protocols and discuss the effects of frequencies and biological resonance on physical tissue based on clinical observations and research. FSM seminars are NOT about the use of microcurrent or microcurrent devices. FSM does not sell or promote devices. FSM teaches the principles and use of biologic resonance and frequencies.

SAFETY

Dr. McMakin has been using FSM since 1994 and various practitioners have been using it since 1997. There have been no permanent adverse effects attributable to the use of the microcurrent units or to the use of the frequencies. There are two effects to be considered- the effect of the current and the effect of the frequencies. The practitioner is protected from the current by wearing latex gloves and is therefore not affected by the current. The practitioner is in the field created by the frequencies and the resonance effect experienced by the patient. This field can be perceived by some practitioners and is either pleasant or bothersome depending on the practitioner’s ability to process the sensations.

The sensation is usually perceived as being “light or floaty” and lasts only as long as the practitioner is using a frequency that is producing a positive effect on the patient. In every class, there is a bell-shaped curve of sensitivity to this sensation. 10% of the class will not feel anything at all in response to the frequencies. 10% of the class will feel a strong sensation of being “floaty or light headed (not dizzy) or slightly “stoned”. The rest of the class will have perceptions someplace in between those two groups. Patients fall into roughly the same bell-shaped curve of sensitivity. The “floaty feeling” response occurs not as a result of any particular frequency but in response to any frequency that resonates with the patient’s condition.

There are no risks to the patient that we know about as long as the practitioner follows the proper contraindications and precautions associated with both FSM and the use of microcurrent. There are frequencies used to remove scar tissue that should not be used with 6 weeks of the time of a new injury. Sometimes when muscles are successfully treated the range of motion increases so much that joints and nerves can become temporarily painful until the range of motion goes back down. Practitioners are aware of these possible reactions and are advised to warn patients about them. After muscles are treated there is sometimes a detoxification reaction that occurs 90 minutes after treatment similar to that seen with massage therapy. This can be lessened by having the patient drink water and take an anti-oxidant combination supplement. The warnings and contraindications appropriate to TENS devices are taught as part of the practicum sessions and reinforced during the lecture.

The Precision Microcurrent machine has a 510K certificate from the FDA meaning that it is approved for sale. All class II microcurrent devices will have a 510k certificate allowing them to be marketed to physicians. The FDA does not approve devices for sale the way it approves drugs for sale. The 510K just means that it can be used in a medical setting and is substantially equivalent to other devices that have been marketed before it. FDA has approved all microcurrent devices for sale in the category of TENS devices. TENS devices are for pain control only and deliver milli-amperage current. ALL TENS devices carry the same warnings precautions and contraindications. Microcurrent devices deliver micro amperage current not milli- amperage current but the warnings for the device are same because all microcurrent devices are approved in the category of TENS devices.

The FDA regulates claims that can be made about therapies, drugs and devices. The claims made for the device can only be those claims that could be made for any device approved in that class of devices and what has been published in a peer reviewed journal regarding its use. Precision Microcurrent and Precision Distributing cannot and do not make any claims about the uses of the Precision Microcurrent device or any microcurrent device or microamperage current beyond what is allowed by the FDA for the class of TENS devices and what has been published in articles in peer reviewed journals. All TENS devices are approved for pain management.

Practitioners are taught during the seminar that FSM should not be used on patients known to be pregnant. TENS devices are not to be used to run current through a pregnant uterus but FSM carries and additional self-imposed recommendation that FSM not be used once a woman is known to be pregnant. No problems have ever been observed in a patient treated who was found later to have been pregnant at the time of treatment so the recommendation is based on prudence rather than negative experience.

The dramatic reductions in cytokines and prostaglandins seen with use of certain frequencies may have an unpredictable effect on the prostaglandins required to maintain a pregnancy. The dramatic order of magnitude changes in neuropeptides seen in the treatment of fibromyalgia from spine trauma may have an unintended effect on a developing fetal nervous system once the fetal nervous system is developed beyond 8 weeks, the time at which most women know they are pregnant.

There can be no claims made for the diagnosis or treatment of any medical condition using frequencies. Science is a method of study not a body of information or a viewpoint. In any scientific endeavor an objective trained observer can make observations of effects. All science starts with observation of a phenomenon and then asks whether the phenomena can be measured and whether it is reproducible and predictable. The scientific method finally sets out to measure and observe the phenomena in a controlled fashion eliminating every other possibility for the observed effect besides the hypothesized mechanism being studied. FSM is in the early stages of this process. The phenomena are physical changes in biological tissue observed to occur only in response to certain specific frequency combinations applied with a microcurrent device delivering square wave pulses on two channels simultaneously. There are certain frequencies that produce effects that can be objectively measured, that are reproducible by any trained practitioner treating the same condition in a hydrated patient and that are predictable. Controlled trials are planned to finally confirm the frequency specific response.