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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 K150681
Device Name GEMORE OTC TENS
Applicant
GEMORE TECHNOLOGY CO., LTD.
11 FL., No.29-5, Sec.2, Chung Cheng E. RD.,
Tan Shui, New Taipei City,  TW 251
Applicant Contact Boden S.P Lai
Correspondent
GEMORE TECHNOLOGY CO., LTD.
11 FL., No.29-5, Sec.2, Chung Cheng E. RD.,
Tan Shui, New Taipei City,  TW 251
Correspondent Contact Boden S.P Lai
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/17/2015
Decision Date 05/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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