510(k) K071113

RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 by Restorative Therapies, Inc. — Product Code GZI

K071113 is an FDA 510(k) premarket notification submitted by Restorative Therapies, Inc. for the device "RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053". The FDA issued a decision of Substantially Equivalent on July 5, 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.