DOMINATOR— 510(k) K983681

Substantially Equivalent

Impact Wheelchair Manufacture, Inc.

FDA 510(k) clearance K983681 for DOMINATOR, Substantially Equivalent on 1998-11-27. Applicant: Impact Wheelchair Manufacture, Inc..

Clearance details

Applicant: Impact Wheelchair Manufacture, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-10-20
Decision date: 1998-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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.