TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02— 510(k) K033097

Substantially Equivalent

Taiwan King Strong Co., Ltd.

FDA 510(k) clearance K033097 for TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02, Substantially Equivalent on 2003-11-12. Applicant: Taiwan King Strong Co., Ltd..

Clearance details

Applicant: Taiwan King Strong Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2003-09-29
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.