Cleared Traditional

K843213 - QUALINE WHEELCHAIR PRODUCTS

K843213 is an FDA 510(k) clearance for QUALINE WHEELCHAIR PRODUCTS, manufactured by Contemporary Health Sys. The device is a Class 2 Physical Medicine device with product code IQC cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K843213 · Contemporary Health Sys · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
9d
Days
Class 2
Risk

K843213 is an FDA 510(k) clearance for the QUALINE WHEELCHAIR PRODUCTS. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Contemporary Health Sys (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 9 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 Contemporary Health Sys devices

FDA 510(k) Submission Details - K843213

510(k) Number K843213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date August 24, 1984
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 K843213.
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