Cleared Traditional

K945153 - MECHANICAL WHEELCHAIR- LIL DIPPER

K945153 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR- LIL DIPPER, 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.

K945153 · Colours 'N Motion · Physical Medicine device
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May 1995
Decision
204d
Days
Class 1
Risk

K945153 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR- LIL DIPPER. 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.

FDA 510(k) Submission Details - K945153

510(k) Number K945153 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 116d · 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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K945153.
MECHANICAL WHEELCHAIR- CHALLENGER
K945149 · Colours 'N Motion · May 1995
MECHANICAL WHEERCHAIR- ECLIPSE
K945150 · Colours 'N Motion · May 1995
MECHANICAL WHEELCHAIR- G-FORCE
K945151 · Colours 'N Motion · May 1995
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
K945153 · MECHANICAL WHEELCHAIR- LIL DIPPER
Download PDF Colours 'N Motion