Cleared Traditional

K090750 - RT300-SL, MODEL FA100052 (FDA 510(k) Clearance)

Also includes:
RT300-SLSA, MODEL FA104581

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090750 · Restorative Therapies, Inc. · Neurology device
Download Printable Device Report (PDF)
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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.

View all Restorative Therapies, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 148d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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