YK9000 SERIES MANUAL WHEELCHAIR— 510(k) K052468

Name: FDA 510(k) clearance K052468
Creator: U.S. Food and Drug Administration
Published: 2005-10-05

Substantially Equivalent

Intco Metal Products (Zhenjiang) Co., Ltd.

FDA 510(k) clearance K052468 for YK9000 SERIES MANUAL WHEELCHAIR, Substantially Equivalent on 2005-10-05. Applicant: Intco Metal Products (Zhenjiang) Co., Ltd.. Device class: 1.

Clearance details

Applicant: Intco Metal Products (Zhenjiang) Co., Ltd.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2005-09-08
Decision date: 2005-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOR

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K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

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.