JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR— 510(k) K112948

Substantially Equivalent

Jiangsu Healthy Way Medical Equipment Co;Ltd

FDA 510(k) clearance K112948 for JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR, Substantially Equivalent on 2012-03-28. Applicant: Jiangsu Healthy Way Medical Equipment Co;Ltd.

Clearance details

Applicant: Jiangsu Healthy Way Medical Equipment Co;Ltd
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2011-10-04
Decision date: 2012-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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.