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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 K200237
Device Name Transcutaneous Electronic Nerve Stimulator
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd
No.3, Xihu industry zone, Xikeng Village, Henggang Town
Longgang District, Shenzhen City,  CN 518115
Applicant Contact Zewu Zhang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Room 2231, Building 1, Ruifeng center, Kaichuang road,
Huangpu district
Guangzhou,  CN 51006
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/24/2020
Decision Date 10/19/2020
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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