Cleared Traditional

K043435 - QUICKIE INTERCHANGE FWD W/LIFT POWER WH...

K043435 is an FDA 510(k) clearance for QUICKIE INTERCHANGE FWD W/LIFT POWER WH..., manufactured by Sunrise Medical. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K043435 · Sunrise Medical · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
60d
Days
Class 2
Risk

K043435 is an FDA 510(k) clearance for the QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sunrise Medical (Somerset, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 60 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sunrise Medical devices

FDA 510(k) Submission Details - K043435

510(k) Number K043435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2004
Decision Date February 11, 2005
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 241
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K043435.
QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
K062701 · Sunrise Medical, Inc. · Sep 2006
WU'S POWERED WHEELCHAIR, MAMBO 2
K052559 · Wu'S Tech Co., Ltd. · Sep 2005
Z-CHAIR
K052353 · Pride Mobility Products Corp. · Sep 2005
WU'S POWERED WHEELCHAIR, MAMBO 36X
K050010 · Wu'S Tech Co., Ltd. · Feb 2005
WU'S POWERED WHEELCHAIR, MAMBO F 120
K050011 · Wu'S Tech Co., Ltd. · Feb 2005
JAZZY 600
K042612 · Pride Mobility Products Corp. · Oct 2004