510(k) K162470

RT300 FES cycle ergometer by Restorative Therapies, Inc. — Product Code GZI

K162470 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT300 FES cycle ergometer". The FDA issued a decision of Substantially Equivalent on July 11, 2017. 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.