Cleared Traditional

K990463 - MEDLINE EXCEL WHEELCHAIRS

K990463 is an FDA 510(k) clearance for MEDLINE EXCEL WHEELCHAIRS, manufactured by Medline. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K990463 · Medline · Physical Medicine device
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Mar 1999
Decision
31d
Days
Class 1
Risk

K990463 is an FDA 510(k) clearance for the MEDLINE EXCEL WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Medline (Mundelein, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 31 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.

FDA 510(k) Submission Details - K990463

510(k) Number K990463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date March 15, 1999
Days to Decision 31 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
85d faster than avg
Panel avg: 116d · This submission: 31d
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 402
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K990463.
KENSTONE
K990139 · Kenda USA · Apr 1999
TISPORT X AND TISPORT XC
K990555 · Tisport · Mar 1999
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
K990557 · Pdg Product Design Group, Inc. · Mar 1999
CROSS SPORT, RIGID WHEELCHAIR
K990358 · Tisport · Feb 1999
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · Invacare Corp. · Feb 1999
MECHANICAL WHEELCHAIR
K984354 · Colours 'N Motion · Jan 1999
K990463 · MEDLINE EXCEL WHEELCHAIRS
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