Product code PFW— Physical Medicine
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
- Classification name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- Regulation
- 21 CFR 890.5300
- Advisory panel
- Physical Medicine
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.”
Market context for product code PFW
FDA has cleared devices under product code PFW between 2008 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2023
- 2022
- 2021
- 2020
- 2013
- 2008
Top applicants under product code PFW
Recent clearances under product code PFW
- K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device
- K233210 — sam CS Long Duration Ultrasound Device
- K223019 — sam 2.0 Long Ultrasound Device
- K221210 — PainShield MD PLUS
- K211513 — sam X1 Long Duration Ultrasound Device
- K191568 — sam 2.0 Long Duration Ultrasound System
- K130978 — ZTX ULTRASONIC DIATHERMY DEVICE
- K081075 — PAINSHIELD MD
- K072256 — HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.