Product code OBP
- Device name
- Transcranial Magnetic Stimulator
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5805
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | 2026-09-06 |
| K260691 | BTL-699 | BTL Industries, Inc. | 2026-08-23 |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | 2026-08-14 |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026-05-22 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026-05-22 |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026-02-20 |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-11-07 |
| K250689 | CloudTMS Edge | Teleemg, LLC | 2025-09-14 |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-09-13 |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025-09-04 |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | 2025-08-18 |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-11 |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-08 |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | 2025-07-30 |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-06-27 |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | 2025-04-17 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | 2025-03-17 |
| K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-02-13 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited | 2024-08-30 |
| K222196 | Deep TMS System | Brainsway , Ltd. | 2024-05-31 |
| K232639 | Apollo TMS Therapy System | Mag & More GmbH | 2024-05-24 |
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024-03-22 |
| K233631 | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | 2024-02-09 |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | 2023-12-29 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | 2023-12-13 |
| K232235 | 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 | The Magstim Company , Ltd. | 2023-10-25 |
| K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | 2023-09-13 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B108699APM1MUS00 | EXOMIND Dual applicator | BTL INDUSTRIES LIMITED | 2026-08-25 |
| 06971538581788 | Neuronavigator | Shenzhen Yingzhi Technology Co.,Ltd. | 2026-08-21 |
| 04260526050118 | Apollo TMS Pro | MAG & More GmbH | 2026-04-09 |
| 00850005944935 | NeuroStar Headrest | NEURONETICS, INC. | 2025-12-15 |
| 00850005944911 | NeuroStar Headrest | NEURONETICS, INC. | 2025-12-09 |
| 05060229530868 | Magstim Double 70mm Air Film Coil | THE MAGSTIM COMPANY LIMITED | 2025-02-19 |
| 00850005944638 | SenStar Treatment Link | NEURONETICS, INC. | 2024-08-02 |
| 00850005944300 | NeuroSITE | NEURONETICS, INC. | 2024-01-03 |
| 00850005944447 | TrakStar Patient Data Management System Software | NEURONETICS, INC. | 2024-01-03 |
| 00850005944553 | TrakStar Patient Data Management System Software | NEURONETICS, INC. | 2024-01-03 |
| 00850005944058 | NeuroStar Advanced Therapy System | NEURONETICS, INC. | 2023-01-02 |
| B108995PORTMSMUS00 | BTL-995-rTMS | BTL INDUSTRIES LIMITED | 2022-12-19 |
| 00850005944218 | SenStar Connect Treatment Link | NEURONETICS, INC. | 2022-10-05 |
| 10850005944239 | Treatment Pack, 50 Pack | NEURONETICS, INC. | 2022-10-05 |
| 00850005944225 | SenStar Treatment Link | NEURONETICS, INC. | 2022-10-05 |
| 00850005944379 | MT Cap | NEURONETICS, INC. | 2022-09-30 |
| 05060229532503 | HORIZON® Ez Cart Mast Extension | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532510 | HORIZON® Ez Cart Arm Assembly | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532527 | StimGuide Trigger Lead | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532534 | StimGuide RS232 Lead | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532558 | Therapy Chair Coil Stand | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532589 | StimGuide BNC Ground Lead | THE MAGSTIM COMPANY LIMITED | 2019-08-29 |
| 05060229532176 | Magstim Rapid² Mains Lead Filter 115V | THE MAGSTIM COMPANY LIMITED | 2016-09-26 |
| 05713484020079 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020024 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484020017 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010087 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010049 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05713484010032 | MagPro | Tonica Elektronik A/S | 2016-09-24 |
| 05060229530462 | Magstim Rapid² Power Supply Single Module 115V | THE MAGSTIM COMPANY LIMITED | 2016-09-23 |