Metallic Fabric Electrodes

Electrode, Cutaneous

Guangzhou Xinbo Electronic Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Metallic Fabric Electrodes.

Pre-market Notification Details

Device IDK202636
510k NumberK202636
Device Name:Metallic Fabric Electrodes
ClassificationElectrode, Cutaneous
Applicant Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou,  CN 511450
ContactSammy Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510006
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970742220193 K202636 000
06970742220186 K202636 000
06970742220179 K202636 000
06970742220162 K202636 000

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