MagVenture Accelerated TMS (aTMS) Therapy System
FDA 510(k) K260189 · Tonica Elektronik A/S
510(k) numberK260189
Submission
- Device name
- MagVenture Accelerated TMS (aTMS) Therapy System
- Applicant
- Tonica Elektronik A/S
Farum, DK - Received
- January 22, 2026
- Decision date
- May 22, 2026
- 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 |
| 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 |
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 09/13/2025SE |
More from Brainsway , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251125 | MagVenture TMS Therapy SystemOBP · Traditional | 08/11/2025SE |
| K251119 | MagVenture TMS Therapy SystemOBP · Traditional | 08/08/2025SE |
| K252032 | T65 (9016E061-)OBP · Special | 07/30/2025SE |
| K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…QPL · Traditional | 08/25/2023SE |
| K221544 | MagVenture TMS Atlas Neuro Navigation SystemHAW · Traditional | 03/17/2023SE |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy systemQCI · Traditional | 08/09/2020SE |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst StimulationOBP · Traditional | 08/14/2018SE |
| K172667 | MagVita TMS Therapy w/MagPro R20OBP · Special | 10/05/2017SE |
| K171967 | MagVita TMS Therapy SystemOBP · Special | 07/25/2017SE |
| K171481 | MagVita TMS Therapy SystemOBP · Special | 06/16/2017SE |
Questions and answers
When was MagVenture Accelerated TMS (aTMS) Therapy System cleared by the FDA?
MagVenture Accelerated TMS (aTMS) Therapy System (K260189) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 120 days after the submission was received.
What is the product code of K260189?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.