Power Wheelchair (D10, D12, D15, D17, D20, D37)— 510(k) K242468

Substantially Equivalent

Anhui Jbh Medical Apparatus Co., Ltd.

FDA 510(k) clearance K242468 for Power Wheelchair (D10, D12, D15, D17, D20, D37), Substantially Equivalent on 2024-12-31. Applicant: Anhui Jbh Medical Apparatus Co., Ltd..

Clearance details

Applicant: Anhui Jbh Medical Apparatus Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2024-08-20
Decision date: 2024-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuzhou, CN

Download summary PDF View on FDA.gov ↗

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.