FDA Product Code IPF: Stimulator, Muscle, Powered
FDA product code IPF covers powered muscle stimulators used in physical medicine and rehabilitation.
These devices deliver low-level electrical impulses to motor nerves or muscle tissue to elicit muscle contractions, preventing atrophy, re-educating paralyzed muscles, and reducing muscle spasm. They are used in the rehabilitation of neurological and orthopedic conditions.
IPF devices are Class II medical devices, regulated under 21 CFR 890.5850 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include BTL Industries, Inc., Shenzhen Dongdixin Technology Co., Ltd. and Edan Instruments, Inc..
List of Stimulator, Muscle, Powered devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stimulator, Muscle, Powered devices (product code IPF). 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 →