Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)— 510(k) K241374

Substantially Equivalent

Anhui Jbh Medical Apparatus Co., Ltd.

FDA 510(k) clearance K241374 for Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009), Substantially Equivalent on 2025-02-28. Applicant: Anhui Jbh Medical Apparatus Co., Ltd..

Clearance details

Applicant: Anhui Jbh Medical Apparatus Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2024-05-15
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuzhou, 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.