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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, for muscle conditioning
510(k) Number K202653
Device Name Gymform Total ABS
Applicant
Well Brain International Ltd.
Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent,
Kwai Chung
Hong Kong,  CN
Applicant Contact Victor K. Wai
Correspondent
Guangzhou Kinda Biological Technology Co., Ltd
6F, No.1 TianTai road, Science City, LuoGang District,
GuangZhou,  CN
Correspondent Contact Jet Li
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received09/14/2020
Decision Date 01/15/2021
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
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