K244041
- 510(k) number
- K244041
- Device name
- Ultrasound Therapy Workstation (XMS-UET2)
- Applicant
- Xemis Medical Technology (Shenzhen) Co., Ltd. CN
- Product code
- IMG — Stimulator, Ultrasound And Muscle, For Use In Applyi
- Decision date
- 2025-10-07
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K244041.pdf
Official FDA record: K244041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.