ROUGHRIDER— 510(k) K103212

Substantially Equivalent

Whirlwind Wheelchair International

FDA 510(k) clearance K103212 for ROUGHRIDER, Substantially Equivalent on 2011-01-03. Applicant: Whirlwind Wheelchair International.

Clearance details

Applicant: Whirlwind Wheelchair International
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2010-11-01
Decision date: 2011-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, 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.