Cleared Traditional

K945149 - MECHANICAL WHEELCHAIR- CHALLENGER

K945149 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR- CHALLENGER, manufactured by Colours 'N Motion. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K945149 · Colours 'N Motion · Physical Medicine device
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May 1995
Decision
204d
Days
Class 1
Risk

K945149 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR- CHALLENGER. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Colours 'N Motion (Anaheim, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 204 days - an extended review 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: 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 Colours 'N Motion devices

FDA 510(k) Submission Details - K945149

510(k) Number K945149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date May 12, 1995
Days to Decision 204 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 115d · This submission: 204d
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 158
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K945149.
BCW ADVANTAGE WHEELCHAIR
K961514 · Wheelchairs of Kansas · May 1996
BUDDY WHEELCHAIR
K960402 · Metro-Care · Feb 1996
QUICKIE TSR
K952641 · Sunrise Medical, Inc. · Jul 1995
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · Invacare Corp. · Mar 1995
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994
STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320
K941088 · Stryker Corp. · Apr 1994