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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 K191982
Device Name Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
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
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
Subsequent Product Code
Date Received07/25/2019
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No