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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., No.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., No.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
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