510(k) K253301— BraiN20® (BraiN20)

Substantially Equivalent

Time IS Brain, S.L.

Clearance details

Applicant: Time IS Brain, S.L.
Product code: Code GWF
Advisory panel: Neurology
Date received: 2025-09-29
Decision date: 2026-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Badalona, ES

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.