OBP

Transcranial Magnetic Stimulator

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(28 件)

数据窗口为最近三年。最新一件:2026-08-23。

510(k) 号批准日期申请人器械名称摘要
K2606912026-08-23BTL Industries, Inc.BTL-699PDF
K2612282026-08-14Brain Ultimate, Inc.QuickVision Ultimate rTMSPDF
K2601892026-05-22Tonica Elektronik A/SMagVenture Accelerated TMS (aTMS) Therapy SystemPDF
K2605602026-05-22Mag & More GmbHApollo TMS Therapy System;Apollo light TMS Therapy SPDF
K2523582026-03-20Nexstim OyjNexstim Navigated Brain Stimulation (NBS) 6 System (PDF
K2530982026-03-20Nexstim OyjNexstim Navigated Brain Stimulation (NBS) 6 System (FDA
K2516532026-02-20Soterix Medical, Inc.SPRY TMS Therapy System (0550)PDF
K2513912025-11-07Brainsway , Ltd.BrainsWay Deep TMS SystemFDA
K2506892025-09-14Teleemg, LLCCloudTMS EdgeFDA
K2514492025-09-13Brainsway , Ltd.BrainsWay Deep TMS SystemPDF
K2437002025-09-04Mag & More GmbHApollo TMS Therapy SystemPDF
K2435392025-08-18Mag & More GmbHApollo TMS Therapy SystemPDF
K2511252025-08-11Tonica Elektronik A/SMagVenture TMS Therapy SystemPDF
K2511192025-08-08Tonica Elektronik A/SMagVenture TMS Therapy SystemPDF
K2520322025-07-30Tonica Elektronik A/ST65 (9016E061-)PDF
K2512102025-06-27Neuromodulatory Devices & ApplicationsAmpa One System (AMPA-001)PDF
K2434602025-04-17Brain Ultimate, Inc.Ultimate rTMSPDF
K2438692025-03-17The Magstim Company LimitedHorizon® 3.0 TMS Therapy System (Horizon 3.0 InspirePDF
K2433192025-02-13Neuromodulatory Devices & ApplicationsAmpa One System (AMPA-001)PDF
K2415182024-08-30The Magstim Company LimitedHorizon® 3.0 TMS Therapy System (Horizon 3.0 InspirePDF
K2221962024-05-31Brainsway , Ltd.Deep TMS SystemPDF
K2326392024-05-24Mag & More GmbHApollo TMS Therapy SystemPDF
K2319262024-03-22Neuronetics, Inc.NeuroStar Advanced Therapy System (All previously clPDF
K2336312024-02-09Revital Lab, Inc.ZapStim Controller Application (Z1023)PDF
K2326882023-12-29Neuroqore, Inc.NQ TMS for MDD (NQv1-MU-01)PDF
K2336212023-12-13NeuroneticsNeuroStar Advanced Therapy System (Version 3.8)PDF
K2322352023-10-25The Magstim Company , Ltd.Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.PDF
K2307352023-09-13Brain Ultimate, Inc.Ultimate rTMS; Yingchi rTMSPDF

其中 25 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。