RTM AND OVAL— 510(k) K080880

Substantially Equivalent

Next Mobility, LLC

FDA 510(k) clearance K080880 for RTM AND OVAL, Substantially Equivalent on 2008-04-09. Applicant: Next Mobility, LLC.

Clearance details

Applicant: Next Mobility, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2008-03-31
Decision date: 2008-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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.