MANUAL WHEELCHAIR— 510(k) K132257

Substantially Equivalent

Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.

FDA 510(k) clearance K132257 for MANUAL WHEELCHAIR, Substantially Equivalent on 2014-02-13. Applicant: Zhejiang Jiafeng Electrical & Mechanial Co., Ltd..

Clearance details

Applicant: Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2013-07-19
Decision date: 2014-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pennington, NJ, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.