A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P— 510(k) K052586

Substantially Equivalent

Taiwan an I Co., Ltd.

FDA 510(k) clearance K052586 for A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P, Substantially Equivalent on 2005-12-09. Applicant: Taiwan an I Co., Ltd..

Clearance details

Applicant: Taiwan an I Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2005-09-20
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, 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.