LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

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 5*5 Cm Square, Lifecare 4*4 Cm Square, Lifecare 5 Cm Round, Lifecare 7.5 Cm Round, Lifecare 4*6 Cm Oval.

Pre-market Notification Details

Device IDK012463
510k NumberK012463
Device Name:LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
ClassificationElectrode, Cutaneous
Applicant EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL.NO.5 LN.155 BEI-SHEND RD. SEC. 3 Shen Keng Hsiang,taipei Hsien,  TW 222
ContactRobert Tu
CorrespondentRobert Tu
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL.NO.5 LN.155 BEI-SHEND RD. SEC. 3 Shen Keng Hsiang,taipei Hsien,  TW 222
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-01
Decision Date2002-02-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816924020321 K012463 000
05060488570957 K012463 000
05060488570964 K012463 000
05060488570971 K012463 000
05060488570988 K012463 000
30816924020137 K012463 000
00816924020143 K012463 000
30816924020175 K012463 000
30816924020182 K012463 000
30816924020199 K012463 000
30816924020205 K012463 000
30816924020229 K012463 000
30850209007000 K012463 000

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