FDA Product Code ISA: Massager, Therapeutic, Electric

Electric massagers provide accessible pain relief and muscle relaxation. FDA product code ISA covers therapeutic electric massagers cleared as medical devices.

These devices use vibration or percussive motion to stimulate soft tissue, improve circulation, and reduce muscle tension for the relief of minor muscular aches and pains. They are available in handheld and stationary configurations for self-use.

ISA devices are Class I medical devices, regulated under 21 CFR 890.5660 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include E.M.S Electro Medical Systems S.A, BTL Industries, Inc. and Shenzhen Dongdixin Technology Co., Ltd..