PFW — Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Class II
Classification Details
- Product Code
- PFW
- Device Class
- Class II
- Regulation Number
- 890.5300
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233210 | zetroz systems | sam CS Long Duration Ultrasound Device | October 25, 2023 |
| K223019 | zetroz systems | sam 2.0 Long Ultrasound Device | June 23, 2023 |
| K221210 | nanovibronix | PainShield MD PLUS | November 23, 2022 |
| K211513 | zetroz systems | sam X1 Long Duration Ultrasound Device | August 18, 2021 |
| K191568 | zetroz systems | sam 2.0 Long Duration Ultrasound System | March 6, 2020 |
| K130978 | zetroz | ZTX ULTRASONIC DIATHERMY DEVICE | November 6, 2013 |
| K081075 | nano vibronix | PAINSHIELD MD | August 22, 2008 |
| K072256 | hill laboratories | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM W | March 12, 2008 |