Cleared Traditional

K984354 - MECHANICAL WHEELCHAIR

K984354 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR, 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 55-day FDA review.

K984354 · Colours 'N Motion · Physical Medicine device
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Jan 1999
Decision
55d
Days
Class 1
Risk

K984354 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR. 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 January 28, 1999 after a review of 55 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.

View all Colours 'N Motion devices

FDA 510(k) Submission Details - K984354

510(k) Number K984354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1998
Decision Date January 28, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 157
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K984354.
MEDLINE EXCEL WHEELCHAIRS
K990463 · Medline · Mar 1999
CROSS SPORT, RIGID WHEELCHAIR
K990358 · Tisport · Feb 1999
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · Invacare Corp. · Feb 1999
ACTIVX
K984367 · Adorno Rogers Technology · Jan 1999
WORLD CLASS WHEELED CHAIR, MODEL SS
K984457 · Suiter Medical LLC · Jan 1999
MODEL ACTION AT II MANUAL WHEELCHAIR
K984447 · Invacare Corp. · Jan 1999