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. .
Category: FSM FAQs