Panels › Physical Medicine › Product code PFW · Class 2
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Regulation 890.5300
1510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PFW
| Company | 510(k)s | Recalls |
|---|---|---|
| ZetrOZ Systems, LLC | 5 | 0 |
| Hill Laboratories Co. | 1 | 0 |
| Nano Vibronix , Ltd. | 1 | 0 |
| Nanovibronix, Inc. | 1 | 0 |
| Zetroz, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2026 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Oct 25, 2023 | K233210 | sam CS Long Duration Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Jun 23, 2023 | K223019 | sam 2.0 Long Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Nov 23, 2022 | K221210 | PainShield MD PLUS Nanovibronix, Inc. | PFW |
| Aug 18, 2021 | K211513 | sam X1 Long Duration Ultrasound Device ZetrOZ Systems, LLC | PFW |
| Mar 6, 2020 | K191568 | sam 2.0 Long Duration Ultrasound System ZetrOZ Systems, LLC | PFW |
| Nov 6, 2013 | K130978 | ZTX ULTRASONIC DIATHERMY DEVICE Zetroz, Inc. | PFW |
| Aug 22, 2008 | K081075 | PAINSHIELD MD Nano Vibronix , Ltd., IL | PFW |
| Mar 12, 2008 | K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL Hill Laboratories Co. | PFW |
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