FRONTIER MODEL X5— 510(k) K030783

Name: FDA 510(k) clearance K030783
Creator: U.S. Food and Drug Administration
Published: 2003-04-04

Substantially Equivalent

Vestil Manufacturing Corp.

FDA 510(k) clearance K030783 for FRONTIER MODEL X5, Substantially Equivalent on 2003-04-04. Applicant: Vestil Manufacturing Corp.. Device class: 2.

Clearance details

Applicant: Vestil Manufacturing Corp.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2003-03-12
Decision date: 2003-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Angola, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.