Self-adhesive Electrode

Electrode, Cutaneous

Bozhou Rongjian Medical Appliance Co.,Ltd.

The following data is part of a premarket notification filed by Bozhou Rongjian Medical Appliance Co.,ltd. with the FDA for Self-adhesive Electrode.

Pre-market Notification Details

Device IDK213879
510k NumberK213879
Device Name:Self-adhesive Electrode
ClassificationElectrode, Cutaneous
Applicant Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou,  CN 233500
ContactZhifang Wu
CorrespondentDoris Dong
Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai,  CN 201613
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-01-05

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