K211513 is an FDA 510(k) clearance for the sam X1 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 August 18, 2021, 96 days after receiving the submission on May 14, 2021.
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 | K211513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | August 18, 2021 |
| Days to Decision | 96 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. |