MILLENIUM II— 510(k) K081665

Name: FDA 510(k) clearance K081665
Creator: U.S. Food and Drug Administration
Published: 2008-06-27

Substantially Equivalent

Next Mobility, LLC

FDA 510(k) clearance K081665 for MILLENIUM II, Substantially Equivalent on 2008-06-27. Applicant: Next Mobility, LLC. Device class: 1.

Clearance details

Applicant: Next Mobility, LLC
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2008-06-13
Decision date: 2008-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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.