Transcutaneous Electronic Nerve Stimulator

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 Transcutaneous Electronic Nerve Stimulator.

Pre-market Notification Details

Device IDK200237
510k NumberK200237
Device Name:Transcutaneous Electronic Nerve Stimulator
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 Received2020-01-24
Decision Date2020-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10810041985702 K200237 000
06924607702485 K200237 000
06924607702492 K200237 000
06924607702508 K200237 000
06924607702515 K200237 000
06924607702522 K200237 000
06924607702539 K200237 000
06924607702546 K200237 000
06924607702553 K200237 000
06924607702560 K200237 000
06924607702577 K200237 000
06924607702607 K200237 000
06924607702614 K200237 000
10810041983807 K200237 000

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