COMED K-SERIES MANUAL WHEELCHAIR— 510(k) K120077

Substantially Equivalent

Danyang Comed Healthcare Co., Ltd.

FDA 510(k) clearance K120077 for COMED K-SERIES MANUAL WHEELCHAIR, Substantially Equivalent on 2012-05-14. Applicant: Danyang Comed Healthcare Co., Ltd..

Clearance details

Applicant: Danyang Comed Healthcare Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2012-01-10
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, VA, US

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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.