POIRIER KID-ROLLER MANUAL WHEELCHAIR— 510(k) K874317

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K874317 for POIRIER KID-ROLLER MANUAL WHEELCHAIR, Substantially Equivalent on 1987-11-17. Applicant: Roseburg SA.

Clearance details

Applicant: Roseburg SA
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1987-10-21
Decision date: 1987-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.