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)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen Kentro Medical Electronics Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for 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).

Pre-market Notification Details

Device IDK191982
510k NumberK191982
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)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District Shenzhen City,  CN 518115
ContactZewu Zhang
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou,  CN 51006
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-25
Decision Date2020-09-25

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