LIFECARE ELECTRODES

Electrode, Cutaneous

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare Electrodes.

Pre-market Notification Details

Device IDK083302
510k NumberK083302
Device Name:LIFECARE ELECTRODES
ClassificationElectrode, Cutaneous
Applicant EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell,  GA  30075
ContactJay Mansour
CorrespondentJay Mansour
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell,  GA  30075
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-10
Decision Date2009-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30816924020120 K083302 000
30816924020083 K083302 000
30816924020076 K083302 000
20816924020062 K083302 000
20816924020048 K083302 000

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