FDA 510(k) Physical Medicine Devices
About Physical Medicine Devices
FDA 510(k) physical medicine devices cover therapeutic and diagnostic equipment used in rehabilitation and physical therapy. The FDA review panel code is PM.
Main categories:
- Electrotherapy devices - TENS, NMES, interferential current and iontophoresis
- Ultrasound therapy - therapeutic ultrasound for musculoskeletal conditions
- Phototherapy systems - low-level laser therapy (LLLT) and LED panels
- Diagnostic ultrasound - musculoskeletal and point-of-care ultrasound systems
- Traction and CPM devices - continuous passive motion and mechanical traction
FDA 510(k) Cleared Physical Medicine Devices
This page lists all 5431 medical devices in the Physical Medicine specialty that have been submitted to the FDA through the 510(k) premarket notification process. Ultrasound therapy, electrotherapy and rehabilitation diagnostic devices.
- 5424 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 115 days.
- Records available from 1976 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 5431 medical devices in the Physical Medicine specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 5424 were cleared as substantially equivalent to a predicate device. Average FDA review time: 115 days. Records from 1976 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to physical medicine
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific physical medicine device? Search by device name, K-number or manufacturer.
Search all Physical Medicine 510(k) devices