EXTREME 4X4-X8 POWER WHEELCHAIR— 510(k) K090350

Substantially Equivalent

Vestil Manufacturing Corp.

FDA 510(k) clearance K090350 for EXTREME 4X4-X8 POWER WHEELCHAIR, Substantially Equivalent on 2009-04-10. Applicant: Vestil Manufacturing Corp..

Clearance details

Applicant: Vestil Manufacturing Corp.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2009-02-11
Decision date: 2009-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Angola, IN, US

Download summary PDF View on FDA.gov ↗

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.