FDA Product Code NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Under FDA product code NFO, transcutaneous electrical nerve stimulators for aesthetic purposes are cleared for cosmetic skin treatments.

These devices deliver low-level electrical stimuli to facial and body skin for cosmetic toning and firming applications, stimulating muscle contractions and improving skin appearance. They are distinct from therapeutic TENS devices cleared for pain management.

NFO devices are Class II medical devices, regulated under 21 CFR 882.5890 and reviewed by the FDA Neurology panel.

Leading manufacturers include Ya-Man, Ltd., BTL Industries, Inc. and Shenzhen Ulike Smart Electronics Co., Ltd..