510(k) K072398

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

K072398 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT300-S AND RT300-SP FES CYCLE ERGOMETER". The FDA issued a decision of Substantially Equivalent on November 21, 2007. 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.