Cleared Traditional

K030017 - CHUMP

K030017 is an FDA 510(k) clearance for CHUMP, 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 119-day FDA review.

K030017 · Colours 'N Motion · Physical Medicine device
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May 2003
Decision
119d
Days
Class 1
Risk

K030017 is an FDA 510(k) clearance for the CHUMP. 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, 2003 after a review of 119 days - within the typical 510(k) review window.

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 - K030017

510(k) Number K030017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date May 01, 2003
Days to Decision 119 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
3d slower than avg
Panel avg: 116d · This submission: 119d
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 K030017.
SHOCKWAVE SUSPENSION WHEELCHAIR
K032123 · Per4max Medical, LLC · Jul 2003
STAINLESS STEEL AQUATIC WHEELCHAIR
K031910 · Db Perks & Associates , Ltd. · Jul 2003
BRODA MODEL 587 MANUAL WHEELCHAIR
K032133 · Broda Ent., Inc. · Jul 2003
GALAXY SERIES WHEELCHAIR
K023993 · Evermed Corp. · Dec 2002
TILITE EVO
K024055 · Tisport, LLC · Dec 2002
MILLENNIUM SERIES MANUAL WHEELCHAIRS
K024030 · Evermed Corp. · Dec 2002
K030017 · CHUMP
Download PDF Colours 'N Motion