Cleared Traditional

K842719 - STANDARD WHEELCHAIR

K842719 is an FDA 510(k) clearance for STANDARD WHEELCHAIR, manufactured by Greene International Corp.. The device is a Class 2 Physical Medicine device with product code IQC cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K842719 · Greene International Corp. · Physical Medicine device
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Jul 1984
Decision
12d
Days
Class 2
Risk

K842719 is an FDA 510(k) clearance for the STANDARD WHEELCHAIR. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Greene International Corp. (Mchenry, US). The FDA issued a Cleared decision on July 25, 1984 after a review of 12 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Greene International Corp. devices

FDA 510(k) Submission Details - K842719

510(k) Number K842719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1984
Decision Date July 25, 1984
Days to Decision 12 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 115d · This submission: 12d
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 16
Devices cleared under the same product code (IQC) and FDA review panel - the closest regulatory comparables to K842719.
MECHANICAL WHEELCHAIR
K120302 · Novaf Andalucia 2007, SL · Jul 2012
RENEGADE WHEELCHAIR
K082857 · Alpha One · Jan 2009
HIPPOCAMPE WHEELCHAIR
K051709 · Vipamat Technologie · Aug 2005
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