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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K193275
Device Name Nerve and Muscle Stimulator
Applicant
Shenzhen XFT Medical Limited
Room 203, Building 1, Biomedicine Innovations Industrial
Park, #14 Jinhui Road,
Shenzhen,  CN
Applicant Contact Cindy Peng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Room 1122#, International Mayors Communication Centre
NO. 55 Shizhou middl
Shenzhen,  CN
Correspondent Contact Field Fu
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received11/26/2019
Decision Date 04/11/2020
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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