Y.E.S POWERED WHEELCHAIR. T180— 510(k) K032512

Substantially Equivalent

Yeou Eir Shuen Machinery Co., Ltd.

FDA 510(k) clearance K032512 for Y.E.S POWERED WHEELCHAIR. T180, Substantially Equivalent on 2003-11-12. Applicant: Yeou Eir Shuen Machinery Co., Ltd..

Clearance details

Applicant: Yeou Eir Shuen Machinery Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2003-08-14
Decision date: 2003-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.