Handbike Batec Electric— 510(k) K241159

Substantially Equivalent

Batec Mobility, S.L.

FDA 510(k) clearance K241159 for Handbike Batec Electric, Substantially Equivalent on 2025-03-07. Applicant: Batec Mobility, S.L..

Clearance details

Applicant: Batec Mobility, S.L.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2024-04-26
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sant Quirze Del Vallès, ES

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.