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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 K172241
Device Name Tyece OTC EMS System, Model EM35
Applicant
Tyece Ltd.
Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd.,
Kowloon Bay
Kowloon,  HK
Applicant Contact Parshid Falahati
Correspondent
Media Trade Corporation
11820 Red Hibiscus Drive
Bonita Springs,  FL  34135
Correspondent Contact Guenter Ginsberg
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/26/2017
Decision Date 11/20/2017
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
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