WU'S POWERED WHEELCHAIR, MAMBO F 120— 510(k) K050011

Substantially Equivalent

Wu'S Tech Co., Ltd.

FDA 510(k) clearance K050011 for WU'S POWERED WHEELCHAIR, MAMBO F 120, Substantially Equivalent on 2005-02-11. Applicant: Wu'S Tech Co., Ltd..

Clearance details

Applicant: Wu'S Tech Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2005-01-03
Decision date: 2005-02-11
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.