510(k) K090750

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 by Restorative Therapies, Inc. — Product Code GZI

K090750 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581". The FDA issued a decision of Substantially Equivalent on August 5, 2009. 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.