PFW
9 FDA 510(k) clearances · Product code
210 daysmedian time to decision
267 days90th percentile
9clearances measured
FDA profile
- Official device name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- FDA definition
- Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SAM 3.0 Multi-Hour Continuous Ultrasound Device (K260076) | ZetrOZ Systems, LLC | 2026-04-28 |
| sam CS Long Duration Ultrasound Device (K233210) | ZetrOZ Systems, LLC | 2023-10-25 |
| sam 2.0 Long Ultrasound Device (K223019) | ZetrOZ Systems, LLC | 2023-06-23 |
| PainShield MD PLUS (K221210) | Nanovibronix, Inc. | 2022-11-23 |
| sam X1 Long Duration Ultrasound Device (K211513) | ZetrOZ Systems, LLC | 2021-08-18 |
| sam 2.0 Long Duration Ultrasound System (K191568) | ZetrOZ Systems, LLC | 2020-03-06 |
| ZTX ULTRASONIC DIATHERMY DEVICE (K130978) | Zetroz, Inc. | 2013-11-06 |
| PAINSHIELD MD (K081075) | Nano Vibronix , Ltd. | 2008-08-22 |
| HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL (K072256) | Hill Laboratories Co. | 2008-03-12 |
Track PFW automatically
Every clearance here is in the API, with alerts when new ones post.