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:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 148d |
| All-time average (cleared) | 115d |
| Not Substantially Equivalent (denied) | 462d |
Recent Physical Medicine submissions have taken longer than the historical average - 148 days in the last 2 years vs 115 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 462 days before receiving a Not Substantially Equivalent determination.
This page lists all 5468 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.
This page lists 5468 medical devices in the Physical Medicine specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 5461 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:
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.
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