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