OBP
- Product code
- OBP
- Device name
- Transcranial Magnetic Stimulator
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5805
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 68
FDA classification definition
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.
510(k) clearances, last 3 years (28)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260691 | 2026-08-23 | BTL Industries, Inc. | BTL-699 | |
| K261228 | 2026-08-14 | Brain Ultimate, Inc. | QuickVision Ultimate rTMS | |
| K260189 | 2026-05-22 | Tonica Elektronik A/S | MagVenture Accelerated TMS (aTMS) Therapy System | |
| K260560 | 2026-05-22 | Mag & More GmbH | Apollo TMS Therapy System;Apollo light TMS Therapy S | |
| K252358 | 2026-03-20 | Nexstim Oyj | Nexstim Navigated Brain Stimulation (NBS) 6 System ( | |
| K253098 | 2026-03-20 | Nexstim Oyj | Nexstim Navigated Brain Stimulation (NBS) 6 System ( | FDA |
| K251653 | 2026-02-20 | Soterix Medical, Inc. | SPRY TMS Therapy System (0550) | |
| K251391 | 2025-11-07 | Brainsway , Ltd. | BrainsWay Deep TMS System | FDA |
| K250689 | 2025-09-14 | Teleemg, LLC | CloudTMS Edge | FDA |
| K251449 | 2025-09-13 | Brainsway , Ltd. | BrainsWay Deep TMS System | |
| K243700 | 2025-09-04 | Mag & More GmbH | Apollo TMS Therapy System | |
| K243539 | 2025-08-18 | Mag & More GmbH | Apollo TMS Therapy System | |
| K251125 | 2025-08-11 | Tonica Elektronik A/S | MagVenture TMS Therapy System | |
| K251119 | 2025-08-08 | Tonica Elektronik A/S | MagVenture TMS Therapy System | |
| K252032 | 2025-07-30 | Tonica Elektronik A/S | T65 (9016E061-) | |
| K251210 | 2025-06-27 | Neuromodulatory Devices & Applications | Ampa One System (AMPA-001) | |
| K243460 | 2025-04-17 | Brain Ultimate, Inc. | Ultimate rTMS | |
| K243869 | 2025-03-17 | The Magstim Company Limited | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire | |
| K243319 | 2025-02-13 | Neuromodulatory Devices & Applications | Ampa One System (AMPA-001) | |
| K241518 | 2024-08-30 | The Magstim Company Limited | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire | |
| K222196 | 2024-05-31 | Brainsway , Ltd. | Deep TMS System | |
| K232639 | 2024-05-24 | Mag & More GmbH | Apollo TMS Therapy System | |
| K231926 | 2024-03-22 | Neuronetics, Inc. | NeuroStar Advanced Therapy System (All previously cl | |
| K233631 | 2024-02-09 | Revital Lab, Inc. | ZapStim Controller Application (Z1023) | |
| K232688 | 2023-12-29 | Neuroqore, Inc. | NQ TMS for MDD (NQv1-MU-01) | |
| K233621 | 2023-12-13 | Neuronetics | NeuroStar Advanced Therapy System (Version 3.8) | |
| K232235 | 2023-10-25 | The Magstim Company , Ltd. | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3. | |
| K230735 | 2023-09-13 | Brain Ultimate, Inc. | Ultimate rTMS; Yingchi rTMS |
Official FDA classification page: OBP
Classification and pathway per current FDA publications. Data from openFDA (CC0).