WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR— 510(k) K120405

Substantially Equivalent

Walk on Wheels Australia Pty, Ltd.

FDA 510(k) clearance K120405 for WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR, Substantially Equivalent on 2012-09-19. Applicant: Walk on Wheels Australia Pty, Ltd..

Clearance details

Applicant: Walk on Wheels Australia Pty, Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2012-02-09
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eugene, OR, 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.