K233210 is an FDA 510(k) clearance for the sam CS Long Duration Ultrasound Device. This device is classified as a Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code PFW).
Submitted by ZetrOZ Systems, LLC (Trumbull, US). The FDA issued a Cleared decision on October 25, 2023, 27 days after receiving the submission on September 28, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300. Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation..
| 510(k) Number | K233210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | October 25, 2023 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | PFW — Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |
| Definition | Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation. |