Cleared Abbreviated

K011744 - HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

K011744 is an FDA 510(k) clearance for HP-5, 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 80-day FDA review.

K011744 · Transworld Mobility Distribution, LLC · Physical Medicine device
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Aug 2001
Decision
80d
Days
Class 2
Risk

K011744 is an FDA 510(k) clearance for the HP-5, BATTERY OPERATED, REAR 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 24, 2001 after a review of 80 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.

FDA 510(k) Submission Details - K011744

510(k) Number K011744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2001
Decision Date August 24, 2001
Days to Decision 80 days
Submission Type Abbreviated
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
36d faster than avg
Panel avg: 116d · This submission: 80d
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 593
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K011744.
M71 POWER WHEELCHAIR
K012927 · Invacare Corp. · Sep 2001
MP3CF ELECTRIC WHEELCHAIR
K012802 · Merits Health Products., Inc. · Sep 2001
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
K011745 · Transworld Mobility Distribution, LLC · Aug 2001
MP3U, POWER WHEELCHAIR
K011513 · Merits Health Products., Inc. · Aug 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · Merits Health Products., Inc. · Aug 2001
TRS-2000 POWER TILT/POWER RECLINE SYSTEM
K012281 · Accelerated Rehab Designs, Inc. · Aug 2001
K011744 · HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
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