Magstim Horizon 3.0 TMS Therapy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211389 FDA 510(k)
- FDA Product Code
- OBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5805 FDA 510(k)
- Regulation Number
- 882.5805 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Magstim Horizon 3.0 TMS Therapy System is a transcranial magnetic stimulator designed to produce and deliver non-invasive magnetic stimulation. It utilizes brief duration, rapidly alternating magnetic fields to provide clinical treatment for conditions including Major Depressive Disorder, OCD, and anxious depression symptoms.
This system is available with or without navigation and has received FDA 510k clearance. It is indicated for use in adult and adolescent patients as specified by its regulatory authorizations. The device is classified under neurology and operates according to regulation number 882.5805.
Frequently asked questions
What conditions is the Magstim Horizon 3.0 indicated to treat?
The system is indicated for the clinical treatment of Major Depressive Disorder, OCD, and anxious depression symptoms in adult and adolescent patients.
How does the Magstim Horizon 3.0 deliver therapy?
The device functions as a transcranial magnetic stimulator that utilizes brief duration, rapidly alternating magnetic fields to provide non-invasive stimulation to the patient.
Is the Magstim Horizon 3.0 available with navigation?
Yes, the system is available in configurations both with and without navigation to suit different clinical requirements.
What is the regulatory status of this device?
The Magstim Horizon 3.0 TMS Therapy System has received FDA 510k clearance under regulation number 882.5805, which classifies it as a neurology device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Horizon 3.0 - Magstim, Horizon 3.0 - Magstim, Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211389 | Class II | Active |
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Manufacturer
- Manufacturer
- Magstim Company, Ltd.
Sources (1)
- FDA 510(k) K211389 24 fields · synced Oct 6, 2026