Velox Power Chair— 510(k) K231315

Substantially Equivalent

Velox Manufacturing, Inc.

FDA 510(k) clearance K231315 for Velox Power Chair, Substantially Equivalent on 2024-01-12. Applicant: Velox Manufacturing, Inc..

Clearance details

Applicant: Velox Manufacturing, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2023-05-05
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langley, CA

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.