EmpowerRide NAVIGATOR— 510(k) K251886

Substantially Equivalent

Empower Ride, LLC

FDA 510(k) clearance K251886 for EmpowerRide NAVIGATOR, Substantially Equivalent on 2026-01-12. Applicant: Empower Ride, LLC.

Clearance details

Applicant: Empower Ride, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2025-06-20
Decision date: 2026-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, NE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.