Power Wheelchair (MOB1107)— 510(k) K250729

Substantially Equivalent

Vive Health, LLC

FDA 510(k) clearance K250729 for Power Wheelchair (MOB1107), Substantially Equivalent on 2025-07-02. Applicant: Vive Health, LLC.

Clearance details

Applicant: Vive Health, LLC
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2025-03-11
Decision date: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, 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.