Cleared Special

K060032 - RT300-S, MODEL FA100052

Also marketed or referenced as:
RT300-SP, MODEL FA100053

K060032 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 64-day FDA review.

K060032 · Restorative Therapies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
64d
Days
Class 2
Risk

K060032 is an FDA 510(k) clearance for the RT300-S, MODEL FA100052. 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 March 10, 2006 after a review of 64 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. 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. Low regulatory complexity profile. 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 - K060032

510(k) Number K060032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2006
Decision Date March 10, 2006
Days to Decision 64 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
85d faster than avg
Panel avg: 149d · This submission: 64d
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 K060032.
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K071486 · Restorative Therapies, Inc. · Sep 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
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329 · Innovative Neurotronics, Inc. · Sep 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991 · Department of Medical Physics and Biomedical Eng. · Jul 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036 · Restorative Therapies, Inc. · Jun 2005