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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, For Pain Relief
510(k) Number K120569
Device Name GEMORE TENS SYSTEM
Applicant
GEMORE TECHNOLOGY CO., LTD.
11 FL, NO. 29-5, SEC. 2
CHUNG CHENG E. RD.
TAN SHUI, TAIPEI HSIEN,  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, TAIPEI HSIEN,  TW 251
Correspondent Contact BODEN S.P. LAI
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received02/27/2012
Decision Date 07/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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