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 BTL Industries, Inc., Shenzhen Dongdixin Technology Co., Ltd. and E.M.S Electro Medical Systems S.A.
List of Massager, Therapeutic, Electric devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Massager, Therapeutic, Electric devices (product code ISA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Physical Medicine FDA review panel. Browse all Physical Medicine devices →