FDA product code PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
PFW is the FDA product code for stationary ultrasonic diathermy device for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel. FDA has cleared 9 510(k) submissions under PFW, 4 in the last five years, from 5 different applicants. The average 510(k) review took 169 days (median 210); 106 days on average over the last three years.
Definition
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Classification
| Field | Value |
|---|---|
| Device name | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5300 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PFW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 267 |
| 2021 | 1 | 96 |
| 2022 | 1 | 210 |
| 2023 | 2 | 147 |
| 2026 | 1 | 106 |
Compare with all 510(k) review times · Search every PFW clearance
Top PFW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ZetrOZ Systems, LLC | 5 | 2026-04-28 |
| Nanovibronix, Inc. | 1 | 2022-11-23 |
| Zetroz, Inc. | 1 | 2013-11-06 |
| Nano Vibronix , Ltd. | 1 | 2008-08-22 |
| Hill Laboratories Co. | 1 | 2008-03-12 |
Most recent PFW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260076 | ZetrOZ Systems, LLC | SAM 3.0 Multi-Hour Continuous Ultrasound Device | 2026-04-28 | 106 |
| K233210 | ZetrOZ Systems, LLC | sam CS Long Duration Ultrasound Device | 2023-10-25 | 27 |
| K223019 | ZetrOZ Systems, LLC | sam 2.0 Long Ultrasound Device | 2023-06-23 | 267 |
| K221210 | Nanovibronix, Inc. | PainShield MD PLUS | 2022-11-23 | 210 |
| K211513 | ZetrOZ Systems, LLC | sam X1 Long Duration Ultrasound Device | 2021-08-18 | 96 |
Recalls for PFW devices
openFDA lists no recalls for product code PFW.
Frequently asked questions
What is FDA product code PFW?
PFW is the FDA product code for stationary ultrasonic diathermy device for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel.
What device class is PFW?
Class II, regulation 21 CFR 890.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFW?
Across 9 cleared submissions the average was 169 days from receipt to decision (median 210).
Which companies have the most PFW clearances?
ZetrOZ Systems, LLC (5); Nanovibronix, Inc. (1); Zetroz, Inc. (1); Nano Vibronix , Ltd. (1); Hill Laboratories Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFW
- Run a recall and safety report across every PFW manufacturer
- Watch product code PFW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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