510(k) K033544

ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 by Everyway Medical Instruments Co.,Ltd — Product Code IPF

K033544 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607". The FDA issued a decision of Substantially Equivalent on Dec 10, 2003. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Everyway Medical Instruments Co.,Ltd has 28 other 510(k) clearances on record.