FDA 510(k) Physical Medicine Devices

FDA 510(k) Physical Medicine Devices - Regulatory Overview

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