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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 K163611
Device Name Pain Therapy Device
Guangzhou Xinbo Electronic Co., Ltd.
2nd Building, Juntuo Industry Park, Xingye Dadao
Nancun Town, Panyu District
Guangzhou,  CN 511400
Applicant Contact Sammy Li
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road
Guangzhou Science Park
Guangzhou,  CN 510000
Correspondent Contact Cecilia Ceng
Regulation Number882.5890
Classification Product Code
Subsequent Product Codes
Date Received12/22/2016
Decision Date 09/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No