OBP
- 产品代码
- OBP
- 器械名称
- Transcranial Magnetic Stimulator
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 882.5805
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 68 件
FDA 分类定义
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.
该代码近三年的 510(k)(28 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页: OBP
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。