PFW
- Product code
- PFW
- Device name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5300
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
FDA classification definition
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260076 | 2026-04-28 | ZetrOZ Systems, LLC | SAM 3.0 Multi-Hour Continuous Ultrasound Device | |
| K233210 | 2023-10-25 | ZetrOZ Systems, LLC | sam CS Long Duration Ultrasound Device |
Official FDA classification page: PFW
Classification and pathway per current FDA publications. Data from openFDA (CC0).