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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)
Dongguan Yingfeng Metal & Plastic Products Co., Ltd
Bianpu District, Lianhu Road, Qiaotou Town
Dongguan,  CN 523520
Applicant Contact Zesheng Chen
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
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