MagVenture Accelerated TMS (aTMS) Therapy System— 510(k) K260189

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K260189 for MagVenture Accelerated TMS (aTMS) Therapy System, Substantially Equivalent on 2026-05-22. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant: Tonica Elektronik A/S
Product code: Code OBP
Advisory panel: Neurology
Date received: 2026-01-22
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farum, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

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.