Cleared Traditional

K982336 - KUSCHALL DESIGN K3/K4 SERIES OF MANUAL ...

K982336 is an FDA 510(k) clearance for KUSCHALL DESIGN K3/K4 SERIES OF MANUAL ..., 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 46-day FDA review.

K982336 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
46d
Days
Class 1
Risk

K982336 is an FDA 510(k) clearance for the KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 46 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 - K982336

510(k) Number K982336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date August 21, 1998
Days to Decision 46 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
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 K982336.
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · Invacare Corp. · Feb 1999
MODEL ACTION AT II MANUAL WHEELCHAIR
K984447 · Invacare Corp. · Jan 1999
MECHANICAL FOLDING WHEEL CHAIR
K973491 · Heartway Medical Products Co., Ltd. · Dec 1997
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · Invacare Corp. · Mar 1995
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994