KENSTONE— 510(k) K990139

Name: FDA 510(k) clearance K990139
Creator: U.S. Food and Drug Administration
Published: 1999-04-29

Substantially Equivalent

Kenda USA

FDA 510(k) clearance K990139 for KENSTONE, Substantially Equivalent on 1999-04-29. Applicant: Kenda USA. Device class: 1.

Clearance details

Applicant: Kenda USA
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1999-01-19
Decision date: 1999-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reynoldsburg, OH, US

Download summary PDF View on FDA.gov ↗

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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.