FX 222-02 POWERED WHEELCHAIR— 510(k) K110036

Substantially Equivalent

Lanzhou Wanli Aviation Electromechanical, Inc.

FDA 510(k) clearance K110036 for FX 222-02 POWERED WHEELCHAIR, Substantially Equivalent on 2011-03-28. Applicant: Lanzhou Wanli Aviation Electromechanical, Inc..

Clearance details

Applicant: Lanzhou Wanli Aviation Electromechanical, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2011-01-05
Decision date: 2011-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, Taiwan, 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.