510(k) K241518— Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

Substantially Equivalent

The Magstim Company Limited

Clearance details

Applicant: The Magstim Company Limited
Product code: Code OBP
Advisory panel: Neurology
Date received: 2024-05-29
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmarthenshire, GB

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.