Does FlexBeam have FDA approval?

Yes! Recharge Health and FlexBeam® achieved EC and CE Electrical Safety Compliance in accordance with the ISO 13485 medical device quality standard, and is registered with the US FDA authorities. In the USA, FlexBeam® is considered a Class II medical device exempted from FDA approval. This means it is a self-certified device that complies with the highest safety and quality standards, and is open for FDA inspection anytime. In the rest of the world FlexBeam is distributed and sold as a wellness device.