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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 K200838
Device Name Tyece OTC TENS Model
Applicant
Tyece Limited
Unit 803, Block A, Po Lung Centre, 11 Wang Chiu Rd,
Kowloon Bay
Kowloon,  CN
Applicant Contact Parshid Falahati
Correspondent
mdi Consultants, Inc.
55 Northern Blvd, Ste 200
Great Neck,  NY  11021
Correspondent Contact Maria Griffin
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/31/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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