PFW · Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5300 · Class 2
Overview
| Product Code | PFW |
|---|---|
| Device Name | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Regulation | 21 CFR 890.5300 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | Oct 25, 2023 | SESE |
| K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | Jun 23, 2023 | SESE |
| K221210 | PainShield MD PLUS | Nanovibronix, Inc. | Nov 23, 2022 | SESE |
| K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | Aug 18, 2021 | SESE |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | Mar 6, 2020 | SESE |
| K130978 | ZTX ULTRASONIC DIATHERMY DEVICE | Zetroz, Inc. | Nov 6, 2013 | SESE |
| K081075 | PAINSHIELD MD | Nano Vibronix , Ltd. | Aug 22, 2008 | SESE |
| K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL | Hill Laboratories Co. | Mar 12, 2008 | SESE |
Top Applicants
- ZetrOZ Systems, LLC — 4 clearances
- Hill Laboratories Co. — 1 clearance
- Nano Vibronix , Ltd. — 1 clearance
- Nanovibronix, Inc. — 1 clearance
- Zetroz, Inc. — 1 clearance
