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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 K233070
Device Name Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
Applicant
Chongqing Rob Linka Science and Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
# 2 Yuekang Rd., Fuxing St., Beibei D
Chongqing,  CN 400700
Applicant Contact Huirong Lu
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 602, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/26/2023
Decision Date 03/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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