Cleared Traditional

K090750 - RT300-SL, MODEL FA100052

Also marketed or referenced as:
RT300-SLSA, MODEL FA104581

K090750 is an FDA 510(k) clearance for RT300-SL, 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 138-day FDA review.

K090750 · Restorative Therapies, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
138d
Days
Class 2
Risk

K090750 is an FDA 510(k) clearance for the RT300-SL, 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 August 5, 2009 after a review of 138 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090750

510(k) Number K090750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date August 05, 2009
Days to Decision 138 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
11d faster than avg
Panel avg: 149d · This submission: 138d
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 K090750.
RT200
K103370 · Restorative Therapies, Inc. · Apr 2011
RT600
K103366 · Restorative Therapies, Inc. · Apr 2011
ODFS PACE
K102115 · Odstock Medical, Ltd. · Mar 2011
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