e-Throne Folding Wheelchair, Model: ET-12F22— 510(k) K191105

Substantially Equivalent

Golden Motor Technology Co., Ltd.

FDA 510(k) clearance K191105 for e-Throne Folding Wheelchair, Model: ET-12F22, Substantially Equivalent on 2022-01-21. Applicant: Golden Motor Technology Co., Ltd..

Clearance details

Applicant: Golden Motor Technology Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2019-04-25
Decision date: 2022-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

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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.