K244041 is an FDA 510(k) clearance for the Ultrasound Therapy Workstation (XMS-UET2). This device is classified as a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMG).
Submitted by Xemis Medical Technology (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 7, 2025, 281 days after receiving the submission on December 30, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5860.
| 510(k) Number | K244041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | October 07, 2025 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMG - Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5860 |