Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
FDA 510(k) K232235 · The Magstim Company , Ltd.
510(k) numberK232235
Submission
- Device name
- Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
- Applicant
- The Magstim Company , Ltd.
Whitland, GB - Received
- July 27, 2023
- Decision date
- October 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBP – Transcranial Magnetic Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Specialty
- Neurology
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Other 510(k)s with product code OBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional | Fidelity BioPharma Co. | 09/06/2026SE |
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional | Mag & More GmbH | 05/22/2026SE |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | Tonica Elektronik A/S | 05/22/2026SE |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K251653 | SPRY TMS Therapy System (0550)OBP · Traditional | Soterix Medical, Inc. | 02/20/2026SE |
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 11/07/2025SE |
| K250689 | CloudTMS EdgeOBP · Traditional | Teleemg, LLC | 09/14/2025SE |
More from Teleemg, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…QPL · Traditional | 07/03/2025SE |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…OBP · Traditional | 03/17/2025SE |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…OBP · Traditional | 08/30/2024SE |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…OBP · Traditional | 03/16/2023SE |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…OBP · Traditional | 01/13/2023SE |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…OBP · Traditional | 09/14/2021SE |
| K203684 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | 03/17/2021SE |
| K183376 | HORIZON TMS Therapy System with NavigationOBP · Traditional | 04/03/2019SE |
| K182853 | HORIZON TMS Therapy SystemOBP · Traditional | 03/15/2019SE |
| K181559 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | 11/09/2018SE |
Questions and answers
When was Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro cleared by the FDA?
Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro (K232235) received a 510(k) decision of Substantially Equivalent on October 25, 2023, 90 days after the submission was received.
What is the product code of K232235?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.