Wheelchair— 510(k) K163352

Substantially Equivalent

Kunshan Hi-Fortune Health Products Co., Ltd.

FDA 510(k) clearance K163352 for Wheelchair, Substantially Equivalent on 2017-07-28. Applicant: Kunshan Hi-Fortune Health Products Co., Ltd..

Clearance details

Applicant: Kunshan Hi-Fortune Health Products Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2016-11-30
Decision date: 2017-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kunshan, CN

Download summary PDF View on FDA.gov ↗

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.