Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

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 Dr-ho's Foot Pad Electrode (models: Dhfre-i, Cp-i, Cp-ii, Cp-iii).

Pre-market Notification Details

Device IDK190118
510k NumberK190118
Device Name:Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
ClassificationElectrode, Cutaneous
Applicant Guangzhou Xinbo Electronic Co., Ltd. 23 Building, Phase-II Huachuang Industry Park Panyu,  CN 511400
ContactSammy Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou,  CN 511400
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-24
Decision Date2020-05-13

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