Cleared Abbreviated

K011745 - HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

K011745 is an FDA 510(k) clearance for HP-3, manufactured by Transworld Mobility Distribution, LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K011745 · Transworld Mobility Distribution, LLC · Physical Medicine device
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Aug 2001
Decision
85d
Days
Class 2
Risk

K011745 is an FDA 510(k) clearance for the HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Transworld Mobility Distribution, LLC (Fort Myers, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Transworld Mobility Distribution, LLC devices

FDA 510(k) Submission Details - K011745

510(k) Number K011745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date August 30, 2001
Days to Decision 85 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 357
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K011745.
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