Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation— 510(k) K211389

Name: FDA 510(k) clearance K211389
Creator: U.S. Food and Drug Administration
Published: 2021-09-14

Substantially Equivalent

Magstim Company, Ltd.

FDA 510(k) clearance K211389 for Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation, Substantially Equivalent on 2021-09-14. Applicant: Magstim Company, Ltd.. Device class: 2.

Clearance details

Applicant: Magstim Company, Ltd.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2021-05-05
Decision date: 2021-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitland, GB

Download summary PDF View on FDA.gov ↗

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K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22

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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.