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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K150386
FOIA Releasable 510(k) K150386
Device Name Tyece OTC TENS Device
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 Dr.
Bonita Springs,  FL  34135
Correspondent Contact Guenter Ginsberg
Regulation Number882.5890
Classification Product Code
NUH  
Date Received02/18/2015
Decision Date 11/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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