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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 K152128
Device Name 2-in-1 Abdominal Muscle Training & Back Pain Relief System
Applicant
Tohkai Precision Electrical Manufactory (Shenzhen) Limited
No.3 Alley 1, Second Industrial Park Park, Jia Zi Tang,
GongMing Office
Shenzhen,  CN 518132
Applicant Contact Yuk Wing Li
Correspondent
GUANGZHOU GLOMED BIOLOGICAL TECHNOLOGY CO.,LTD
SUITE 306, KECHENG MANSION, NO.121 SCIENCE ROAD,
GUANGZHOU SCIENCE PARK
GUANGZHOU,  CN 510663
Correspondent Contact CECILIA CENG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received07/31/2015
Decision Date 12/23/2015
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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