LERADO, COSCO— 510(k) K050290

Substantially Equivalent

Lerado Oversea Ltd. Twn Branch (Bvi)

FDA 510(k) clearance K050290 for LERADO, COSCO, Substantially Equivalent on 2005-02-18. Applicant: Lerado Oversea Ltd. Twn Branch (Bvi).

Clearance details

Applicant: Lerado Oversea Ltd. Twn Branch (Bvi)
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2005-02-07
Decision date: 2005-02-18
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.