Cleared Special

K030427 - HP-3 HD ELECTRIC WHEELCHAIR

K030427 is an FDA 510(k) clearance for HP-3 HD ELECTRIC WHEELCHAIR, manufactured by Imc-Heart Way LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 67-day FDA review.

K030427 · Imc-Heart Way LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
67d
Days
Class 2
Risk

K030427 is an FDA 510(k) clearance for the HP-3 HD ELECTRIC WHEELCHAIR. 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 April 18, 2003 after a review of 67 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imc-Heart Way LLC devices

FDA 510(k) Submission Details - K030427

510(k) Number K030427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date April 18, 2003
Days to Decision 67 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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
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