510(k) K103719

LIFECARE CONDUCTIVE GARMENTS by Everyway Medical Instruments Co.,Ltd — Product Code GXY

K103719 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "LIFECARE CONDUCTIVE GARMENTS". The FDA issued a decision of Substantially Equivalent on August 24, 2011. 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 at least 10 other 510(k) clearances on record.