GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM

Electrode, Cutaneous

GMDASZ MANUFACTURING CO., LTD

The following data is part of a premarket notification filed by Gmdasz Manufacturing Co., Ltd with the FDA for Gmdasz Tens Electrodes, Models Cwn1005, Dia. 5cm, Dwn2505, 5cmx5cm, Cwn1007.dia. 7cm, Cwn2509,5cmx9cm.

Pre-market Notification Details

Device IDK092546
510k NumberK092546
Device Name:GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
ClassificationElectrode, Cutaneous
Applicant GMDASZ MANUFACTURING CO., LTD 77325 JOYCE WAY Echo,  OR  97826
ContactCharlie Mack
CorrespondentCharlie Mack
GMDASZ MANUFACTURING CO., LTD 77325 JOYCE WAY Echo,  OR  97826
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-19
Decision Date2009-12-18
Summary:summary

NIH GUDID Devices

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