Cleared Traditional

K082857 - RENEGADE WHEELCHAIR

K082857 is an FDA 510(k) clearance for RENEGADE WHEELCHAIR, manufactured by Alpha One. The device is a Class 2 Physical Medicine device with product code IQC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K082857 · Alpha One · Physical Medicine device
Download Printable Device Report (PDF)
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Jan 2009
Decision
99d
Days
Class 2
Risk

K082857 is an FDA 510(k) clearance for the RENEGADE WHEELCHAIR. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Alpha One (Chevy Chase, US). The FDA issued a Cleared decision on January 6, 2009 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3880 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Alpha One devices

FDA 510(k) Submission Details - K082857

510(k) Number K082857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date January 06, 2009
Days to Decision 99 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IQC Device Classification - Class 2, Special Controls

Product Code IQC Wheelchair, Special Grade
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3880
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.

Regulatory Peers - IQC Wheelchair, Special Grade

All 13
Devices cleared under the same product code (IQC) and FDA review panel - the closest regulatory comparables to K082857.
Hippocampe Marathon and Trail
K251570 · Vipamat Sarl · Jun 2025
POIRIER VARIABLE WHEELCHAIR
K840234 · Poirier S.A. · Feb 1984
UNION WHEELCHAIR
K840625 · Poirier S.A. · Feb 1984
AMPUTEE WHEELCHAIR
K840627 · Poirier S.A. · Feb 1984
LARGE FRONT WHEELS WHEELCHAIR
K840628 · Poirier S.A. · Feb 1984
POIRIER REGLADE WHEELCHAIR
K840630 · Poirier S.A. · Feb 1984