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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 K181728
Device Name Muscle Trainer
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
#3, Xihu Industry Zone, Xikeng Village, Henggang Town
Longgang District
Shenzhen,  CN 518115
Applicant Contact Zewu Zhang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center
,Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number890.5850
Classification Product Code
NGX  
Date Received06/29/2018
Decision Date 10/17/2018
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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