FDA product code PFW

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Physical Medicine·Class 2·21 CFR 890.5300
US regulatory classifications
US Product Code (FDA)
PFW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 890.5300
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
Definition

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

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About this record

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.