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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 116d · 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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K030427.
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · Sunrise Medical, Inc. · May 2003
SUNPEX TECHNOLOGIES MODEL PW
K024175 · Sunpex Technology Co., Ltd. · May 2003
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
K030432 · Imc-Heart Way LLC · May 2003
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · Wu'S Tech Co., Ltd. · Apr 2003
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · Wu'S Tech Co., Ltd. · Apr 2003
FRONTIER MODEL X5
K030783 · Vestil Manufacturing Corp. · Apr 2003
K030427 · HP-3 HD ELECTRIC WHEELCHAIR
Download PDF FDA Summary Imc-Heart Way LLC