KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS— 510(k) K982336

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K982336 for KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS, Substantially Equivalent on 1998-08-21. Applicant: Invacare Corp..

Clearance details

Applicant: Invacare Corp.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-07-06
Decision date: 1998-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.