Cleared Traditional

K884932 - INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR

K884932 is an FDA 510(k) clearance for INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR, manufactured by Invacare Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K884932 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
14d
Days
Class 1
Risk

K884932 is an FDA 510(k) clearance for the INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on December 12, 1988 after a review of 14 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 Invacare Corp. devices

FDA 510(k) Submission Details - K884932

510(k) Number K884932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date December 12, 1988
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
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 91
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K884932.
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
RIDE-LITE 9000 SERIES WHEELCHAIR
K881951 · Invacare Corp. · May 1988
ROLLS 2000 SERIES WHEELCHAIR
K881762 · Invacare Corp. · May 1988
POIRIER KID-ROLLER MANUAL WHEELCHAIR
K874317 · Roseburg SA · Nov 1987