510(k) K242791— Electric wheelchair (KR-8807)

Substantially Equivalent

Zhejiang Kairui Medical Device Co., Ltd.

Clearance details

Applicant: Zhejiang Kairui Medical Device Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2024-09-16
Decision date: 2024-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ruian, CN

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.