Cleared Traditional

K885330 - WHEELCHAIR

K885330 is the FDA 510(k) clearance for WHEELCHAIR by Kaye Products, Inc.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K885330 · Kaye Products, Inc. · Physical Medicine device
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Feb 1989
Decision
37d
Days
Class 1
Risk

K885330 is an FDA 510(k) clearance for the WHEELCHAIR, MECHANICAL. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Kaye Products, Inc. (Durham, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 37 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 Kaye Products, Inc. devices

Submission Details

510(k) Number K885330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date February 03, 1989
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 88
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K885330.
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
ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)
K884931 · Invacare Corp. · Dec 1988
INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR
K884932 · Invacare Corp. · Dec 1988
RIDE-LITE 9000 SERIES WHEELCHAIR
K881951 · Invacare Corp. · May 1988