WHEELCHAIR, MODELS H001A, 4422— 510(k) K000738

Substantially Equivalent

Jackson Company, LLC

FDA 510(k) clearance K000738 for WHEELCHAIR, MODELS H001A, 4422, Substantially Equivalent on 2000-05-26. Applicant: Jackson Company, LLC.

Clearance details

Applicant: Jackson Company, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2000-03-07
Decision date: 2000-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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.