Cleared Traditional

K051302 - EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELC...

K051302 is the FDA 510(k) clearance for EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELC... by Medline Industries, Inc.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K051302 · Medline Industries, Inc. · Physical Medicine device
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Aug 2005
Decision
88d
Days
Class 1
Risk

K051302 is an FDA 510(k) clearance for the EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 15, 2005 after a review of 88 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K051302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2005
Decision Date August 15, 2005
Days to Decision 88 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 77
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K051302.
Kuschall Advance Manual Wheelchair
K162696 · Invacare Corporation · Dec 2016
MyOn HC Manual Wheelchair
K152536 · Invacare Corporation · Jan 2016
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · Medline Industries, Inc. · Dec 2001
SOLARA JR. MANUAL WHEELCHAIR
K012370 · Invacare Corp. · Aug 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · Invacare Corp. · Aug 2001