FDA Product Code
FDA Product Code OBP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5805
510(k) Clearances — 69 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | 2026-09-06 | Traditional | PDF ↗ |
| K260691 | BTL-699 | BTL Industries, Inc. | 2026-08-23 | Traditional | PDF ↗ |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | 2026-08-14 | Traditional | PDF ↗ |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026-05-22 | Traditional | PDF ↗ |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026-05-22 | Traditional | PDF ↗ |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 | Traditional | PDF ↗ |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 | Traditional | PDF ↗ |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-11-07 | Traditional | PDF ↗ |
| K250689 | CloudTMS Edge | Teleemg, LLC | 2025-09-14 | Traditional | PDF ↗ |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-09-13 | Traditional | PDF ↗ |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025-09-04 | Traditional | PDF ↗ |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | 2025-08-18 | Traditional | PDF ↗ |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-11 | Traditional | PDF ↗ |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-08 | Traditional | PDF ↗ |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | 2025-07-30 | Special | PDF ↗ |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-06-27 | Special | PDF ↗ |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | 2025-04-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-02-13 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K222196 | Deep TMS System | Brainsway , Ltd. | 2024-05-31 | Traditional | PDF ↗ |
| K232639 | Apollo TMS Therapy System | Mag & More GmbH | 2024-05-24 | Traditional | PDF ↗ |
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024-03-22 | Traditional | PDF ↗ |
| K233631 | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | 2024-02-09 | Traditional | PDF ↗ |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | 2023-12-29 | Traditional | PDF ↗ |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | 2023-12-13 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | 2023-09-13 | Traditional | PDF ↗ |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023-04-04 | Traditional | PDF ↗ |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Company, Ltd. | 2023-03-16 | Traditional | PDF ↗ |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | Magstim Company, Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | Magnus Medical, Inc. | 2022-09-01 | Traditional | PDF ↗ |
| K220819 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2022-08-26 | Traditional | PDF ↗ |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | Neuronetics, Inc. | 2022-08-24 | Special | PDF ↗ |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Neuronetics, Inc. | 2022-07-15 | Traditional | PDF ↗ |
| K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System | Remed Co., Ltd. | 2022-04-06 | Special | PDF ↗ |
| K212723 | BTL-995-rTMS | BTL Industries, Inc. | 2022-03-04 | Traditional | PDF ↗ |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | Neuronetics, Inc. | 2021-12-10 | Special | PDF ↗ |
| K202537 | ALTMS Magnetic Stimulation Therapy System | Remed Co., Ltd. | 2021-11-26 | Traditional | PDF ↗ |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | Magstim Company, Ltd. | 2021-09-14 | Traditional | PDF ↗ |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway , Ltd. | 2021-08-17 | Traditional | PDF ↗ |
| K203735 | Brainsway Deep TMS System | Brainsway , Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020-11-20 | Traditional | PDF ↗ |
| K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019-04-03 | Traditional | PDF ↗ |
| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2019-03-22 | Traditional | PDF ↗ |
| K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019-03-15 | Traditional | PDF ↗ |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018-08-14 | Traditional | PDF ↗ |
| K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018-08-03 | Traditional | PDF ↗ |
| K180313 | Apollo TMS Therapy System | Mag & More GmbH | 2018-05-04 | Abbreviated | PDF ↗ |
| K173540 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | 2018-05-03 | Traditional | PDF ↗ |
| K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017-12-13 | Special | PDF ↗ |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017-11-10 | Traditional | PDF ↗ |
| K172667 | MagVita TMS Therapy w/MagPro R20 | Tonica Elektronik A/S | 2017-10-05 | Special | PDF ↗ |
| K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017-09-13 | Traditional | PDF ↗ |
| K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017-07-25 | Special | PDF ↗ |
| K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017-06-16 | Special | PDF ↗ |
| K170114 | MagVita TMS Therapy - w/MagPro R20 | Tonica Elektronik A/S | 2017-05-01 | Traditional | PDF ↗ |
| K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017-03-10 | Traditional | PDF ↗ |
| K160309 | Neurosoft TMS | Teleemg, LLC | 2016-12-22 | Traditional | PDF ↗ |
| K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016-09-11 | Traditional | PDF ↗ |
| K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016-06-10 | Traditional | PDF ↗ |
| K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015-07-31 | Traditional | PDF ↗ |
| K143531 | Rapid Therapy System | Magstim Company Limited | 2015-05-08 | Traditional | PDF ↗ |
| K133408 | NEUROSTAR TMS THERAPY SYSTEM | Neuronetics | 2014-03-28 | Traditional | PDF ↗ |
| K130233 | NEUROSTAR TMS THERAPY SYSTEM | Neuronetics | 2013-04-30 | Traditional | PDF ↗ |
| K122288 | BRAINSWAY DEEP TMS SYSTEM | Brainsway , Ltd. | 2013-01-07 | Traditional | PDF ↗ |
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | Neuronetics | 2008-12-16 | Special | PDF ↗ |
| DEN070003 | NEUROSTAR TMS SYSTEM | Neuronetics | 2008-10-07 | Post-NSE | — |
Product code OBP · Class II · Neurology. Data: openFDA.