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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K244041
Device Name Ultrasound Therapy Workstation (XMS-UET2)
Applicant
Xemis Medical Technology (Shenzhen) Co., Ltd.
1101/1102/1201/1202, Unit 1, Bldg. 2, Hongpeng Bldg.,
Tiegang Community, Xixiang St., Baoan
Shenzhen,  CN 518102
Applicant Contact Yongfen Yang
Correspondent
Chonconn Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number890.5860
Classification Product Code
IMG  
Subsequent Product Codes
GZI   GZJ   IPF   LIH  
Date Received12/30/2024
Decision Date 10/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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