FDA approved?
The Precision Microcurrent machine has a 510K certificate from the FDA meaning that it is approved for sale. 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 and deliver milli-amperage current. ALL TENS devices carry the same warnings precautions and contraindications. Microcurrent devices do not function like TENS devices but they are approved in the category of TENS. They deliver micro amperage current not milli- amperage current. The warnings for the device have to be the same because of FDA requirements even though they do not actually apply to microcurrent. There is no special class of devices that can be created for microcurrent. The cost would be in the millions of dollars and there is no gua
