Cleared Traditional

K910747 - FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR

K910747 is an FDA 510(k) clearance for FORTRESS AEROEDGE 3-WHEEL MANUAL RACING..., manufactured by Fortress Litestyle. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K910747 · Fortress Litestyle · Physical Medicine device
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Mar 1991
Decision
28d
Days
Class 1
Risk

K910747 is an FDA 510(k) clearance for the FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Fortress Litestyle (Washington, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 28 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 Fortress Litestyle devices

FDA 510(k) Submission Details - K910747

510(k) Number K910747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date March 21, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 253
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K910747.
ACTION FX MANUAL WHEELCHAIR
K921847 · Invacare Corp. · May 1992
VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR
K920391 · Invacare Corp. · Feb 1992
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS
K914553 · Invacare Corp. · Oct 1991
ELLIPSE 2.3
K905621 · Everest & Jennings, Inc. · Dec 1990
S.P.F. PREMIER 2 WHEELCHAIR
K904152 · Everest & Jennings, Inc. · Sep 1990
WORLD CHAIR
K894136 · Invacare Corp. · Jul 1989