I actually think that the technology as described would not require FDA approval to be sold, but it might require the same for health insurance claims coverage. It is similar to a tens machine and tens machines have been marketed for a long time and are already approved at the advice of physicians for physical therapy, particularly sorts of tens machine for diabetic neuropathies of the feet and legs. I personally have no idea of the efficaciousness of the tens machines but would love to hear from anyone on the forum who has used them.