Cleared Traditional

K071113 - RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053

K071113 is an FDA 510(k) clearance for RT300-S, manufactured by Restorative Therapies, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K071113 · Restorative Therapies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
76d
Days
Class 2
Risk

K071113 is an FDA 510(k) clearance for the RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Restorative Therapies, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 5, 2007 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K071113

510(k) Number K071113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2007
Decision Date July 05, 2007
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 149d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZI Device Classification - Class 2, Special Controls

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 55
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K071113.
REHASTIM & REHAMOVE
K073237 · Hasomed GmbH · Dec 2007
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K072398 · Restorative Therapies, Inc. · Nov 2007
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K071486 · Restorative Therapies, Inc. · Sep 2007
NESS L300
K053468 · Ness-Neuromuscular Electrical Stimulation Systems · Jul 2006
RT300-S, MODEL FA100052
K060032 · Restorative Therapies, Inc. · Mar 2006
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329 · Innovative Neurotronics, Inc. · Sep 2005