Adhesive Electrodes

Electrode, Cutaneous

Voncare Medical Device Co., Ltd

The following data is part of a premarket notification filed by Voncare Medical Device Co., Ltd with the FDA for Adhesive Electrodes.

Pre-market Notification Details

Device IDK212191
510k NumberK212191
Device Name:Adhesive Electrodes
ClassificationElectrode, Cutaneous
Applicant Voncare Medical Device Co., Ltd Shiwan Science And Technology Industrial Park, Yongshi Avenue East Boluo County, Huizhou,  CN 516127
ContactJimmy Zhai
CorrespondentCharles Mack
IRC 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-12
Decision Date2021-10-06

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