Three lanes
Non-invasive bone growth stimulators, including PEMF, came to market through premarket approval as Class III devices.FDA panel 2020 Non-thermal shortwave therapy is a Class II prescription device for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue.21 CFR 890.5290 Products that stay with general wellness claims follow FDA’s low-risk wellness policy.FDA wellness policy
What that means in the practice
A wellness mat cannot be marketed for a medical condition. A cleared device can be marketed for its cleared indication, on prescription. Evidence also differs by use: Cleveland Clinic notes PEMF is still being studied.Cleveland Clinic Ask for the product code, the regulation and the exact indication before you buy.
General information for licensed practices, not legal or medical advice. Sources are linked in the text.