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510(k) K244041

Ultrasound Therapy Workstation (XMS-UET2) by Xemis Medical Technology (Shenzhen) Co., Ltd. — Product Code IMG

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

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