Stimulator, Electrical, Evoked Response
FDA product code GWF · Class II (moderate risk) · 21 CFR 882.1870 · Neurology
140510(k) clearances
0PMA approvals
16recalls
Manufacturers
- Cadwell Laboratories, Inc. 12
- Axon Systems, Inc. 7
- Nihon Kohden America, Inc. 7
- Tracor Northern, Inc. 6
- Excel Tech. , Ltd. 6
- Nuvasive, Inc. 5
- Dantec Medical, Inc. 5
- Tonica Elektronik A/S 5
- Teca, Inc. 4
- Dantec Electronics, Inc. 4
- Alphatec Spine, Inc. 3
- The Magstim Company , Ltd. 3
- Bio-Logic Systems Corp. 3
- Inomed Medizintechnik GmbH 3
- Natus Neurology Inc 3
- Siegen Corp. 2
- Medelec , Ltd. 2
- Nicolet Instrument Corp. 2
- Medtronic Xomed, Inc. 2
- Nexstim OY 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253301 | BraiN20® (BraiN20)GWF · Traditional | Time IS Brain, S.L. | 06/27/2026SE |
| K252842 | SafeOp 3: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 01/11/2026SE |
| K243982 | Nicolet EDXGWF · Special | Natus Neurology Incorporated | 01/22/2025SE |
| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
| K234092 | SafeOp 3: Neural Informatix SysteemGWF · Traditional | Alphatec Spine, Inc. | 04/19/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | Soterix Medical, Inc. | 03/25/2024SE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special | Inomed Medizintechnik GmbH | 10/27/2023SE |
| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
| K213849 | SafeOp 2: Neural Informatix SystemGWF · Traditional | Alphatec Spine, Inc. | 03/09/2022SE |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Traditional | Inomed Medizintechnik GmbH | 01/07/2022SE |
| K192823 | Mega-TmsGWF · Traditional | Soterix Medical, Inc. | 08/13/2021SE |
| K190703 | Neuro-IOM system with Neuro-IOM.NET softwareGWF · Traditional | Neurosoft , Ltd. | 05/22/2021SE |
| K200759 | NIM Vital, Nerve Integrity MonitorGWF · Traditional | Medtronic Xomed, Inc. | 10/28/2020SE |
| K182542 | The EPAD 2 SystemGWF · Traditional | Safeop Surgical, Inc. | 02/22/2019SE |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView SoftwareGWF · Special | Neurovision Medical Product, Inc. | 04/05/2017SE |
| K162873 | MEP MonitorGWF · Traditional | Tonica Elektronik A/S | 03/31/2017SE |
| K162199 | Cascade IOMAX Intraoperative MonitorGWF · Traditional | Cadwell Industries, Inc. | 03/02/2017SE |
| K160280 | MagPro R20GWF · Traditional | Tonica Elektronik A/S | 05/16/2016SE |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-FastGWF · Traditional | Eb Neuro S.P.A. | 08/19/2015SE |
| K142624 | Neuromaster G1 MEE200GWF · Traditional | Nihon Kohden Corporation | 04/24/2015SE |
| K132616 | EpadGWF · Traditional | Safeop Surgical, Inc. | 01/24/2014SE |
| K130403 | Magstim Double 70-2 CoilGWF · Special | The Magstim Company , Ltd. | 08/23/2013SE |
| K123843 | Neuroepg SystemGWF · Traditional | Strohl Medical Technologies | 06/05/2013SE |
| K130346 | Synergy Focus Desktop Version; Synergy Focus Laptop VersionGWF · Special | Natus Neurology Incorporated | 05/02/2013SE |
| K120397 | MEB-2300A Neuropack Evoked Potential and Emg Measuring SystemGWF · Traditional | Nihon Kohden Corp. | 09/19/2012SE |
| K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with…GWF · Traditional | Nexstim OY | 05/22/2012SE |
| K120979 | Carefusion Nicolet EdxGWF · Special | Carefusion 209, Inc. | 04/25/2012SE |
| K112052 | Carefusion Nicolet EdxGWF · Traditional | Carefusion 209, Inc. | 03/15/2012SE |
| K111647 | C2 Nervemonitor System with AccessoriesGWF · Traditional | Inomed Medizintechnik GmbH | 10/06/2011SE |
| K110140 | Neurovision Nerve Locator MonitorGWF · Traditional | Neurovision Medical Products, Inc. | 09/30/2011SE |
| K093304 | Protektor 32GWF · Traditional | Natus Medical, Inc. | 08/11/2010SE |
| K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeGWF · Special | Nuvasive, Inc. | 05/14/2010SE |
| K091940 | Magpro, Models R30 with Magoption, X100, X100 with MagoptionGWF · Traditional | Tonica Elektronik A/S | 03/26/2010SE |
| K091457 | Nexstim Eximia Navigated Brain Stimulation SystemGWF · Abbreviated | Nexstim OY | 12/08/2009SE |
| K083371 | Navigator Pro with Aep Software (Biomark, Enog, Champ)GWF · Traditional | Natus Medical, Inc. | 12/08/2009SE |
| K090298 | Nuvasive Neuro Vision SystemGWF · Traditional | Nuvasive, Inc. | 06/08/2009SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | Laborie Medical Technologies, Inc. | 03/06/2009SE |
| K083124 | Nim 3.0GWF · Traditional | Medtronic Xomed, Inc. | 02/27/2009SE |
| K080499 | Magstim Double 70MM Air Film Coil, Model 3910-00GWF · Traditional | The Magstim Company , Ltd. | 12/08/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | Nihon Kohden America, Inc. | 10/06/2008SE |
| K072343 | Neurovision JJB SystemGWF · Traditional | Nuvasive, Inc. | 10/29/2007SE |
| K071821 | Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65GWF · Special | Tonica Elektronik A/S | 07/27/2007SE |
| K062765 | Modification to Nuvasive Neurovision JJB SystemGWF · Special | Nuvasive, Inc. | 01/24/2007SE |
| K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…GWF · Traditional | Axon Systems, Inc. | 11/01/2006SE |
| K061645 | Magpro, Model R30GWF · Traditional | Tonica Elektronik A/S | 10/31/2006SE |
| K060847 | Magstim 200-2GWF · Traditional | Magstim Company Us, LLC | 09/26/2006SE |
| K061113 | OrthomonGWF · Traditional | Axon Systems, Inc. | 05/23/2006SE |
| K051864 | Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00GWF · Traditional | The Magstim Company , Ltd. | 12/21/2005SE |
| K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…GWF · Traditional | Digitimer , Ltd. | 09/20/2005SE |
| K051178 | MEE-1000A NeuromasterGWF · Traditional | Nihon Kohden America, Inc. | 08/17/2005SE |
| K050798 | Eclipse Neurological WorkstationGWF · Traditional | Axon Systems, Inc. | 08/15/2005SE |
| K051384 | Modification to: Nuvasive Neurovision JJB SystemGWF · Special | Nuvasive, Inc. | 07/11/2005SE |
| K030526 | Pediguard Nerve Detector SystemGWF · Traditional | Spine Vision, Inc. | 12/29/2004SE |
| K042350 | TES-1 Constant Voltage Electrical StimulatorGWF · Traditional | Cadwell Laboratories, Inc. | 11/03/2004SE |
| K040358 | Xltek Protektor Stimulator, Models 10247 & 10248GWF · Traditional | Excel Tech. , Ltd. | 08/06/2004SE |
| K031930 | High Speed Emg ModuleGWF · Traditional | Medical Measurement Systems B.V. | 03/03/2004SE |
| K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationGWF · Traditional | Axon Systems, Inc. | 12/16/2003SE |
| K020400 | Digitimer D185 Multipulse Cortical StimulatorGWF · Traditional | Meps, LLC | 08/23/2002SE |
| K010092 | Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed)GWF · Traditional | Excel Tech. , Ltd. | 04/02/2001SE |
| K010090 | Xltek Evoked Potential Headbox, Model EP-4-RP (Proposed)GWF · Traditional | Excel Tech. , Ltd. | 03/26/2001SE |
| K010087 | Xltek Real Patient Evoked Potential Headbox, Model EP-16-RPGWF · Traditional | Excel Tech. , Ltd. | 03/19/2001SE |
| K002969 | Xltek Evoked Potential Headbox, Model EP-8GWF · Traditional | Xltek | 12/08/2000SE |
| K002773 | Neuromap with Neuro 100GWF · Traditional | Radionics, Inc. | 10/23/2000SE |
| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | Airsep Corp. | 10/20/2000SE |
| K001101 | Xltek Evoked Potential Headbox, Model EP-4GWF · Traditional | Excel Tech. , Ltd. | 06/30/2000SE |
| K992911 | Magstim RapidGWF · Traditional | Magstim Corporation US | 01/07/2000SE |
| K991899 | Nihon Kohden MEB-2200A Neuropack Evoked Potential & Emg Measuring System with AccessoriesGWF · Traditional | Nihon Kohden America, Inc. | 09/01/1999SE |
| K992313 | XL Tek Evoked Potential Headbox, Model EP-16GWF · Traditional | Excel Tech. , Ltd. | 08/19/1999SE |
| K981405 | Synergy LTGWF · Traditional | Oxford Instruments, Plc. | 07/16/1998SE |
| K980866 | Medi-Dx 7000 CPT with Amrex ElectrodesGWF · Traditional | Neuro-Diagnostic Assoc. | 05/20/1998SE |
| K971740 | Amplaid MK12GWF · Traditional | Amplifon S.P.A. | 03/16/1998SE |
| K972959 | Amplaid MK22GWF · Traditional | Amplifon S.P.A. | 02/06/1998SE |
| K971819 | Epoch 2000 Neurological WorkstationGWF · Traditional | Axon Systems, Inc. | 11/20/1997SE |
| K965065 | Teca. MillenniumGWF · Traditional | Medelec , Ltd. | 06/20/1997SE |
| K963662 | Galileo Evoked PotentialreGWF · Traditional | Biosound, Inc. | 02/26/1997SE |
| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | Cadwell Laboratories, Inc. | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | Cadwell Laboratories, Inc. | 01/13/1997SE |
| K962455 | Four-Channel PreamplifierGWF · Traditional | Cadwell Laboratories, Inc. | 01/13/1997SE |
| K932994 | Evoked Potential SYSTEM-1.0GWF · Traditional | Neuromedical Systems, Inc. | 04/15/1996SE |
| K960170 | Electroencephalograph (EEG)GWF · Traditional | Moberg Medical, Inc. | 03/01/1996SE |
| K955257 | SS102 Dual Channel Sep StimulatorGWF · Traditional | Axon Systems, Inc. | 02/02/1996SE |
| K952294 | NeuronetGWF · Traditional | Computational Diagnostics, Inc. | 01/26/1996SE |
| K944547 | Dantec KeypointGWF · Traditional | Mckenna & Cuneo | 09/19/1995SE |
| K950208 | Nihon Kohden Neuropack Sigma MEB-5500A Evoked Response & Emg Measuring SystemGWF · Traditional | Nihon Kohden America, Inc. | 05/10/1995SE |
| K931923 | Dantec Maglite Magnetic Stimulator (Maglite)GWF · Traditional | Dantec Medical, Inc. | 11/09/1993SE |
| K926516 | Dantec Magnetic Stimulator MagproGWF · Traditional | Dantec Medical, Inc. | 08/31/1993SE |
| K931428 | Cadwell 6200 aGWF · Traditional | Cadwell Laboratories, Inc. | 06/22/1993SE |
| K924723 | Cadwell SierraGWF · Traditional | Cadwell Laboratories, Inc. | 03/23/1993SE |
| K924127 | Dantec EvolutionGWF · Traditional | Dantec Medical, Inc. | 03/10/1993SE |
| K923303 | Sapphire PremiereGWF · Traditional | Medelec , Ltd. | 11/24/1992SE |
| K923315 | Nicolet Ark SystemGWF · Traditional | Nicolet Instrument Corp. | 11/23/1992SE |
| K912685 | MEM-4204-4-8, MEB-4204 &4208 Evoke Potent Meas SysGWF · Traditional | Nihon Kohden America, Inc. | 02/26/1992SE |
| K915652 | Nicolet Poratble Spirit SystemGWF · Traditional | Nicolet Instrument Corp. | 02/07/1992SE |
| K912775 | Sapphire 4ME Emg/Ep SystemGWF · Traditional | Medelec Intl. Corp. | 11/08/1991SE |
| K905059 | High Speed Magnetic StimulatorGWF · Traditional | Cadwell Laboratories, Inc. | 09/18/1991SE |
| K902607 | Dantec Magnetic Stimulator Mag 2 (Mag 2)GWF · Traditional | Dantec Medical, Inc. | 05/14/1991SE |
| K903731 | Sapphire Series 1P, 1L, 2L, and 2MEGWF · Traditional | Teca, Inc. | 02/04/1991SE |
| K894560 | Qsi 9000GWF · Traditional | Quantified Signal Imaging, Inc. | 08/08/1990SE |
| K900482 | Software & Hardware Addition to SENTINEL-4 EEGGWF · Traditional | Axon Systems, Inc. | 06/20/1990SE |
| K896567 | Cantata Emg/Evoked Response SystemGWF · Traditional | Dantec Medical, Inc. | 02/16/1990SE |
| K894608 | Model 4000 Evoked Potential Measurement SystemGWF · Traditional | Micro-Shev , Ltd. | 12/29/1989SE |
| K890274 | MEM-7102; MEB-7102 Evoked Response & Electro RecorGWF · Traditional | Nihon Kohden America, Inc. | 05/18/1989SE |
| K885246 | AdvantageGWF · Traditional | Clark Davis Medical Systems, Inc. | 02/27/1989SE |
| K884870 | Teca/Medelec 'Concept' P420GWF · Traditional | Teca, Inc. | 02/23/1989SE |
| K883340 | Neural Magnetic Stimulator, the D190GWF · Traditional | Tracor Northern, Inc. | 12/29/1988SE |
| K881915 | Dantec Magnetic StimulatorGWF · Traditional | Dantec Electronics, Inc. | 10/17/1988SE |
| K880088 | Cadwell ExcelGWF · Traditional | Cadwell Laboratories, Inc. | 05/04/1988SE |
| K870567 | Evoport 300GWF · Traditional | Dantec Electronics, Inc. | 10/06/1987SE |
| K871964 | Siegen Neuroscope Seeg for Evoked Response Stimu.GWF · Traditional | Siegen Corp. | 10/01/1987SE |
| K872106 | Dantec CounterpointGWF · Traditional | Dantec Electronics, Inc. | 09/10/1987SE |
| K871338 | Novametrix Model 200 MagstimGWF · Traditional | Novametrix Medical Systems, Inc. | 08/04/1987SE |
| K863175 | Ees 10 Electrodeless Electrical StimulatorGWF · Traditional | Cadwell Laboratories, Inc. | 01/13/1987SE |
| K862690 | Traveler LTGWF · Traditional | Bio-Logic Systems Corp. | 11/25/1986SE |
| K861900 | Lifescan Evoked Potential SystemGWF · Traditional | Neurometrics | 08/25/1986SE |
| K860968 | TM-3400, Nomad (Modified)GWF · Traditional | Tracor Northern, Inc. | 08/18/1986SE |
| K855232 | Somatosensory Evoked Potential StimulatorGWF · Traditional | Neuroscience, Inc. | 07/03/1986SE |
| K860903 | TM-3600 a Neurodiagnostic SystemGWF · Traditional | Tracor Northern, Inc. | 06/05/1986SE |
| K860240 | Cns-Ep System and Ep 1.0 SoftwareGWF · Traditional | Cns, Inc. | 04/17/1986SE |
| K851300 | Neuropack 8, MEE-4108GWF · Traditional | Nihon Kohden America, Inc. | 06/13/1985SE |
| K844992 | Bio-Logic Portable Evoked Response SystemGWF · Traditional | Bio-Logic Systems Corp. | 06/07/1985SE |
| K850109 | Nomad TM-3400GWF · Traditional | Tracor Northern, Inc. | 06/04/1985SE |
| K843815 | Evomatic 8000/4000GWF · Traditional | Dantec Electronics, Inc. | 05/31/1985SE |
| K844707 | Quantum 84GWF · Traditional | Cadwell Laboratories, Inc. | 05/21/1985SE |
| K843712 | Audit TM VGWF · Traditional | Axonics, Inc. | 04/05/1985SE |
| K842543 | Evoked Potential SysGWF · Traditional | Bio-Logic Systems Corp. | 11/29/1984SE |
| K843464 | Siegen NeuroscopeGWF · Traditional | Siegen Corp. | 11/20/1984SE |
| K843253 | Emg/Ncv & Evoked Response, Design W/GWF · Traditional | Neurodiagnostics, Inc. | 11/20/1984SE |
| K831896 | Compact FourGWF · Traditional | Nicolet Biomedical Instruments | 07/28/1983SE |
| K830771 | Cadwell 8400GWF · Traditional | Cadwell Laboratories, Inc. | 04/12/1983SE |
| K822744 | #ST10 Progr. Evoked Response StimulatorGWF · Traditional | Teca, Inc. | 11/03/1982SE |
| K822396 | The 3500GWF · Traditional | Tracor Northern, Inc. | 09/24/1982SE |
| K822214 | Cadwell 7400GWF · Traditional | Cadwell Laboratories, Inc. | 09/24/1982SE |
| K820908 | Teca Model Sensor Er 94GWF · Traditional | Teca, Inc. | 05/03/1982SE |
| K820414 | Universal Testing & Analysis SystemsGWF · Traditional | Lkc Technologies, Inc. | 03/04/1982SE |
| K811848 | Model Six Beam SystemGWF · Traditional | Braintech, Inc. | 09/08/1981SE |
| K810482 | Somatosensory StimulatorGWF · Traditional | Amplaid USA, Inc. | 04/29/1981SE |
| K810560 | TN-3000 Evoked Response SystemGWF · Traditional | Tracor Northern, Inc. | 03/17/1981SE |
| K781704 | Stimulator, TN-3001 SomatosensoryGWF · Traditional | Tracor Instruments, Inc. | 12/01/1978SE |
| K780539 | Stimulator Model 8021GWF · Traditional | Life-Tech Instruments, Inc. | 06/22/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2793-2026 Class II | SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemIntraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of… | Alphatec Spine, Inc. | 05/13/2026Open, Classified |
| Z-1623-2025 Class II | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE…Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which… | Medtronic Xomed, Inc. | 03/10/2025Open, Classified |
| Z-2409-2024 Class I | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital…Potential for false negative response on the NIM Vital Nerve Monitoring System | Medtronic Xomed, Inc. | 06/24/2024Open, Classified |
| Z-2349-2024 Class II | Cascade IOMAX Cortical Module, REF: 190296-200Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage… | Cadwell Industries Inc | 05/17/2024Open, Classified |
| Z-1882-2024 Class II | Cascade IOMAX Cortical Module, REF: 190296-200There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly… | Cadwell Industries Inc | 04/23/2024Open, Classified |
| Z-1224-2022 Class II | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2Software anomaly was identified. | Medtronic Xomed, Inc. | 05/03/2022Open, Classified |
| Z-1223-2022 Class II | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2Software anomaly was identified. | Medtronic Xomed, Inc. | 05/03/2022Open, Classified |
| Z-2320-2017 Class II | NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw…Software defect: the NBS software may accidentally generate duplicate copies of one or several files. | Nexstim PLC | 03/14/2017Open, Classified |
| Z-2319-2017 Class II | Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain…Software defect: the NBS software may accidentally generate duplicate copies of one or several files. | Nexstim PLC | 03/14/2017Open, Classified |
| Z-1068-2015 Class II | EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative…Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform… | Natus Medical Incorporated | 01/02/2015Terminated |
| Z-1407-2013 Class II | Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103…Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of… | Alpine Biomed Aps | 04/09/2013Terminated |
| Z-0817-2016 Class II | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK…The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which… | Nihon Kohden America Inc | 01/19/2012Terminated |
| Z-2344-2012 Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient…In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic… | Medtronic Xomed, Inc. | 09/27/2010Terminated |
| Z-2343-2012 Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient…In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic… | Medtronic Xomed, Inc. | 09/27/2010Terminated |
| Z-2342-2012 Class II | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient…In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic… | Medtronic Xomed, Inc. | 09/27/2010Terminated |
| Z-0218-2007 | Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of…When the device is subject to physical shock, such as a drop to the floor, it may output a different value… | Nihon Kohden America Inc | 08/23/2006Terminated |