Cleared Traditional

K072153 - QUICKIE QX MANUAL FOLDING WHEELCHAIR

K072153 is an FDA 510(k) clearance for QUICKIE QX MANUAL FOLDING WHEELCHAIR, manufactured by Sunrise Medical, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K072153 · Sunrise Medical, Inc. · Physical Medicine device
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Sep 2007
Decision
38d
Days
Class 1
Risk

K072153 is an FDA 510(k) clearance for the QUICKIE QX MANUAL FOLDING WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Sunrise Medical, Inc. (Fresno, US). The FDA issued a Cleared decision on September 10, 2007 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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, Inc. devices

FDA 510(k) Submission Details - K072153

510(k) Number K072153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2007
Decision Date September 10, 2007
Days to Decision 38 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 97
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K072153.
Kuschall Advance Manual Wheelchair
K162696 · Invacare Corporation · Dec 2016
MyOn HC Manual Wheelchair
K152536 · Invacare Corporation · Jan 2016
KIDS ROCK 3 CHAIR
K111739 · Pride Mobility Products Corp. · Aug 2011
INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
K060582 · Invacare Corporation · Mar 2006
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · Medline Industries, Inc. · Aug 2005