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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 K190988
Device Name GIM-STIM OTC TENS/EMS System
Applicant
Gemore Technology Co, Ltd.
11fl., #29-5, Sec.2, Chug Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Applicant Contact Boden S.P. Lai
Correspondent
Gemore Technology Co, Ltd.
11fl., #29-5, Sec.2, Chug Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Correspondent Contact Boden S.P. Lai
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received04/15/2019
Decision Date 08/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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