Cleared Abbreviated

K063203 - ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)

K063203 is an FDA 510(k) clearance for ELECTRIC 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 113-day FDA review.

K063203 · Imc-Heart Way LLC · Physical Medicine device
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Feb 2007
Decision
113d
Days
Class 2
Risk

K063203 is an FDA 510(k) clearance for the ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4). 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 February 13, 2007 after a review of 113 days - within the typical 510(k) review window.

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 - K063203

510(k) Number K063203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2006
Decision Date February 13, 2007
Days to Decision 113 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
3d faster than avg
Panel avg: 116d · This submission: 113d
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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K063203.
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
K070489 · Heartway Medical Products Co., Ltd. · Mar 2007
ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
K063307 · Imc-Heart Way LLC · Feb 2007
ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
K063320 · Imc-Heart Way LLC · Feb 2007
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
K063475 · Imc-Heart Way LLC · Jan 2007
ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
K063474 · Imc-Heart Way LLC · Dec 2006
MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
K062888 · Emg Technology Co., Ltd. · Oct 2006
K063203 · ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
Download PDF Imc-Heart Way LLC