Cleared Traditional

K041072 - KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT

K041072 is an FDA 510(k) clearance for KUSCHALL CHAMPION, manufactured by Invacare Corporation. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K041072 · Invacare Corporation · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
16d
Days
Class 1
Risk

K041072 is an FDA 510(k) clearance for the KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on May 12, 2004 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 - K041072

510(k) Number K041072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date May 12, 2004
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 116d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K041072.
FS SERIES WHEELCHAIR
K041814 · Foshan Dongfang Medical Equipment Manufactory(Ltd) · Jul 2004
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
K041337 · Pro Walker, Inc. · May 2004
COMBI SELF PROPELLED SHOWER COMMODE
K040677 · Kjaerulff Rehabilitation A/S · May 2004
FREEDOM HP
K040622 · Freedom Designs, Inc. · Apr 2004
MANUAL WHEELCHAIR SERIES
K040561 · Shanghai Wheelchair Factory · Mar 2004
CHEETAH WHEELCHAIR
K033460 · R82 A/S · Mar 2004
K041072 · KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
Download PDF FDA Summary Invacare Corporation