WHEELCHAIR (MANUAL, NOT ELECTRICAL)— 510(k) K992884

Substantially Equivalent

Foshan Machinery & Equipment Import & Export Co.

FDA 510(k) clearance K992884 for WHEELCHAIR (MANUAL, NOT ELECTRICAL), Substantially Equivalent on 1999-11-02. Applicant: Foshan Machinery & Equipment Import & Export Co..

Clearance details

Applicant: Foshan Machinery & Equipment Import & Export Co.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1999-08-25
Decision date: 1999-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lee, NJ, US

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.