510(k) K012463

LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL by Everyway Medical Instruments Co.,Ltd — Product Code GXY

K012463 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL". The FDA issued a decision of Substantially Equivalent on Feb 5, 2002. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Everyway Medical Instruments Co.,Ltd has 28 other 510(k) clearances on record.