Wrap Accessory Electrodes

Electrode, Cutaneous

Hi-Dow International Inc.

The following data is part of a premarket notification filed by Hi-dow International Inc. with the FDA for Wrap Accessory Electrodes.

Pre-market Notification Details

Device IDK210383
510k NumberK210383
Device Name:Wrap Accessory Electrodes
ClassificationElectrode, Cutaneous
Applicant Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights,  MO  63043
ContactEric Chen
CorrespondentEric Chen
Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights,  MO  63043
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-11-12

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