← FDA Medical Device Classifications
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
PFW · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5300
Classification
- FDA Product Code
PFW- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.5300
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 10
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown