510(k) K244041
K244041 is an FDA 510(k) premarket notification submitted by Xemis Medical Technology (Shenzhen) Co., Ltd. for the device "Ultrasound Therapy Workstation (XMS-UET2)". The FDA issued a decision of Substantially Equivalent on October 7, 2025. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Xemis Medical Technology (Shenzhen) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2025
- Date Received
- December 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5860
- Review Panel
- PM
- Submission Type