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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 K183454
Device Name Tyece OTC EMS System
Applicant
Tyece Ltd.
Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd.
Kowloon Bay
Kowloon, Hong Kong,  HK
Applicant Contact Parshid Falahati
Correspondent
Media Trade Corporation
11820 Red Hibiscus Dr
Bonita Springs,  FL  34135
Correspondent Contact Guenter Ginsberg
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/13/2018
Decision Date 02/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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