FDA Product Code
FDA Product Code PFW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5300
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026-04-28 | Special | PDF ↗ |
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2023-10-25 | Special | PDF ↗ |
| K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023-06-23 | Traditional | PDF ↗ |
| K221210 | PainShield MD PLUS | Nanovibronix, Inc. | 2022-11-23 | Special | PDF ↗ |
| K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021-08-18 | Special | PDF ↗ |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020-03-06 | Traditional | PDF ↗ |
| K130978 | ZTX ULTRASONIC DIATHERMY DEVICE | Zetroz, Inc. | 2013-11-06 | Traditional | PDF ↗ |
| K081075 | PAINSHIELD MD | Nano Vibronix , Ltd. | 2008-08-22 | Traditional | PDF ↗ |
| K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL | Hill Laboratories Co. | 2008-03-12 | Traditional | PDF ↗ |
Product code PFW · Class II · Physical Medicine. Data: openFDA.