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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 K183103
Device Name EMS Belt (Model MC0485)
Applicant
Dongguan Yingfeng Metal & Plastic Products Co., Ltd
Bianpu District, Lianhu Road, Qiaotou Town
Dongguan,  CN 523520
Applicant Contact Zesheng Chen
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number890.5850
Classification Product Code
NGX  
Date Received11/07/2018
Decision Date 09/18/2019
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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