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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 K232517
Device Name Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
Shenzhen Kentro Medical Electronics Co., Ltd.
2nd Floor, No. 11, Shanzhuang Road, Xikeng Village
Yuanshan Street, Longgang District
Shenzhen,  CN
Applicant Contact Zewu Zhang
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received08/18/2023
Decision Date 12/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No