BrainsWay Deep TMS System
FDA 510(k) K251391 · Brainsway , Ltd.
510(k) numberK251391
Submission
- Device name
- BrainsWay Deep TMS System
- Applicant
- Brainsway , Ltd.
Jerusalem, IL - Received
- May 5, 2025
- Decision date
- November 7, 2025
- 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 |
| 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 |
|---|---|---|
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | 09/13/2025SE |
| K222196 | Deep TMS SystemOBP · Traditional | 05/31/2024SE |
| K220819 | BrainsWay Deep TMS SystemOBP · Traditional | 08/26/2022SE |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) SystemOBP · Traditional | 08/17/2021SE |
| K203735 | Brainsway Deep TMS SystemOBP · Traditional | 04/23/2021SE |
| K203616 | Brainsway Deep (DTMS) SystemQMD · Traditional | 04/16/2021SE |
| K200957 | Brainsway Deep TMS SystemQMD · Traditional | 08/21/2020SE |
| K183303 | Brainsway Deep TMS SystemQCI · Traditional | 03/08/2019SE |
| K173540 | Brainsway Deep (DTMS) SystemOBP · Traditional | 05/03/2018SE |
| K122288 | Brainsway Deep TMS SystemOBP · Traditional | 01/07/2013SE |
Questions and answers
When was BrainsWay Deep TMS System cleared by the FDA?
BrainsWay Deep TMS System (K251391) received a 510(k) decision of Substantially Equivalent on November 7, 2025, 186 days after the submission was received.
What is the product code of K251391?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.