Is the ReBuilder FDA approved?
If you mean is it fully registered with the FDA, then yes it is. It is registered under the 510K basis as both a TENS and an EMS, (which is the only two categories that the FDA offers). The FDA does not approve any medical device, the FDA only “approves” pharmaceuticals. It has a registration process for medical devices and the ReBuilder fully meets all national state and county requirements and registrations. The ReBuilder is fully covered by product liability insurance and has not had any claim in 18 years. There have been no complaints or investigations registered by the FDA in 18 years.
