Cleared Traditional

K801317 - QUADRA WHEELCHAIR, QUADRA CHAIR, ETC.

K801317 is an FDA 510(k) clearance for QUADRA WHEELCHAIR, manufactured by Quadra Wheelchairs, Inc.. The device is a Class 2 Physical Medicine device with product code IQC cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K801317 · Quadra Wheelchairs, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1980
Decision
48d
Days
Class 2
Risk

K801317 is an FDA 510(k) clearance for the QUADRA WHEELCHAIR, QUADRA CHAIR, ETC.. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Quadra Wheelchairs, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 48 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.

FDA 510(k) Submission Details - K801317

510(k) Number K801317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date July 21, 1980
Days to Decision 48 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 116d · This submission: 48d
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 23
Devices cleared under the same product code (IQC) and FDA review panel - the closest regulatory comparables to K801317.
TRAIL CHAIR
K834498 · Winchester Industries, Inc. · Jan 1984
BASE ONLY, TORONTO CHAIR
K832322 · Intl. Medical Equipment Corp. · Aug 1983
FREEDOM 19 RECREATIONAL WHEELCHAIR
K831510 · Carbonite Corp. · Jul 1983
AVON TILTING PUSH CHAIR 14
K770147 · Maddak, Inc. · Feb 1977
YORKHILL CHAIR
K770145 · Maddak, Inc. · Jan 1977
K801317 · QUADRA WHEELCHAIR, QUADRA CHAIR, ETC.
Download PDF Quadra Wheelchairs, I…