Cleared Abbreviated

K052008 - IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7

K052008 is an FDA 510(k) clearance for IMC HEARTWAY - POWER WHEELCHAIR, manufactured by Imc-Heart Way LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 53-day FDA review.

K052008 · Imc-Heart Way LLC · Physical Medicine device
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Sep 2005
Decision
53d
Days
Class 2
Risk

K052008 is an FDA 510(k) clearance for the IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Imc-Heart Way LLC (Fort Myers, US). The FDA issued a Cleared decision on September 16, 2005 after a review of 53 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 Imc-Heart Way LLC devices

FDA 510(k) Submission Details - K052008

510(k) Number K052008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2005
Decision Date September 16, 2005
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
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 325
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K052008.
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K050011 · Wu'S Tech Co., Ltd. · Feb 2005