Cleared Traditional

K945152 - MECHANICAL WHEELCHAIR- IMPACT

K945152 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR- IMPACT, 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 193-day FDA review.

K945152 · Colours 'N Motion · Physical Medicine device
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May 1995
Decision
193d
Days
Class 1
Risk

K945152 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR- IMPACT. 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 1, 1995 after a review of 193 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.

FDA 510(k) Submission Details - K945152

510(k) Number K945152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date May 01, 1995
Days to Decision 193 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
77d slower than avg
Panel avg: 116d · This submission: 193d
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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K945152.
MECHANICAL WHEELCHAIR 890.3850
K945175 · Lumex, Inc. · May 1995
CHAMPION
K950815 · Kleinfeld, Kaplan and Becker · May 1995
AVANTGARDE
K951847 · Otto Bock Orthopedic Industry, Inc. · May 1995
X2000 TRADITIONAL WHEELCHAIR
K951351 · Homecrest Industries · Apr 1995
RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
K951560 · Radius Intl., Inc. · Apr 1995
SUN-BURST
K951120 · Kid'S Wheel-Chairs · Apr 1995
K945152 · MECHANICAL WHEELCHAIR- IMPACT
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