COMMUTER (MANUAL/POWER WHEELCLHAIR)— 510(k) K934232

Substantially Equivalent for Some Indications

Fortress Lite-Style Wheelchairs, Inc.

FDA 510(k) clearance K934232 for COMMUTER (MANUAL/POWER WHEELCLHAIR), Substantially Equivalent for Some Indications on 1994-03-29. Applicant: Fortress Lite-Style Wheelchairs, Inc..

Clearance details

Applicant: Fortress Lite-Style Wheelchairs, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1993-08-19
Decision date: 1994-03-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, 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.