Cleared Traditional

K042699 - ABILITY POWER GURNEY

K042699 is an FDA 510(k) clearance for ABILITY POWER GURNEY, manufactured by Gator Custom Mobility, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K042699 · Gator Custom Mobility, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
167d
Days
Class 2
Risk

K042699 is an FDA 510(k) clearance for the ABILITY POWER GURNEY. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Gator Custom Mobility, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 167 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Gator Custom Mobility, Inc. devices

FDA 510(k) Submission Details - K042699

510(k) Number K042699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2004
Decision Date March 16, 2005
Days to Decision 167 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 338
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K042699.
A-200 POWERED WHEELCHAIR
K052706 · Otto Bock Healthcare LP · Dec 2005
WU'S POWERED WHEELCHAIR, MAMBO 2
K052559 · Wu'S Tech Co., Ltd. · Sep 2005
Z-CHAIR
K052353 · Pride Mobility Products Corp. · Sep 2005
WU'S POWERED WHEELCHAIR, MAMBO 36X
K050010 · Wu'S Tech Co., Ltd. · Feb 2005
WU'S POWERED WHEELCHAIR, MAMBO F 120
K050011 · Wu'S Tech Co., Ltd. · Feb 2005
HOVEROUND SE-3 POWERCHAIR
K042920 · Hoveround Corp. · Dec 2004