APEX Manual Wheelchair— 510(k) K161425

Substantially Equivalent

Motion Composites

FDA 510(k) clearance K161425 for APEX Manual Wheelchair, Substantially Equivalent on 2016-12-05. Applicant: Motion Composites.

Clearance details

Applicant: Motion Composites
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2016-05-23
Decision date: 2016-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Roch-De-L'Achigan, 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.