Cleared Special

K071486 - RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

K071486 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 Special 510(k) pathway after a 103-day FDA review.

K071486 · Restorative Therapies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
103d
Days
Class 2
Risk

K071486 is an FDA 510(k) clearance for the RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, 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 September 10, 2007 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071486

510(k) Number K071486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date September 10, 2007
Days to Decision 103 days
Submission Type Special
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
46d faster than avg
Panel avg: 149d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

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 K071486.
MODIFICATION TO:NESS L300
K080219 · Ness-Neuromuscular Electrical Stimulation Systems · Feb 2008
REHASTIM & REHAMOVE
K073237 · Hasomed GmbH · Dec 2007
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K072398 · Restorative Therapies, Inc. · Nov 2007
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
K071113 · Restorative Therapies, Inc. · Jul 2007
NESS L300
K053468 · Ness-Neuromuscular Electrical Stimulation Systems · Jul 2006
RT300-S, MODEL FA100052
K060032 · Restorative Therapies, Inc. · Mar 2006