Cleared Abbreviated

THE LIBERATOR (K984391) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K984391 · Liberator Wheelchairs, Inc. · Physical Medicine device
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Sep 1999
Decision
269d
Days
Class 2
Risk

K984391 is an FDA 510(k) clearance for the THE LIBERATOR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Liberator Wheelchairs, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 269 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Liberator Wheelchairs, Inc. devices

Submission Details

510(k) Number K984391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date September 03, 1999
Days to Decision 269 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 Physical Medicine devices follow this clearance model.

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All 65
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