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., Weero Co., Ltd. and Shenzhen Dongdixin Technology Co., Ltd..
FDA 510(k) Cleared Stimulator, Muscle, Powered Devices (Product Code IPF)
About Product Code IPF - Regulatory Context
510(k) Submission Activity
545 total 510(k) submissions under product code IPF since 1976, with 545 receiving FDA clearance (average review time: 157 days).
Submission volume has declined in recent years - 8 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under IPF have taken an average of 257 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.
IPF devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →