510(k) K050036

FES CYCLE ERGOMETER, MODEL RT300-S by Restorative Therapies, Inc. — Product Code GZI

K050036 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "FES CYCLE ERGOMETER, MODEL RT300-S". The FDA issued a decision of Substantially Equivalent on June 27, 2005. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Restorative Therapies, Inc. has at least 9 other 510(k) clearances on record.