GWF · Stimulator, Electrical, Evoked Response
Neurology · 21 CFR 882.1870 · Class 2
Overview
| Product Code | GWF |
|---|---|
| Device Name | Stimulator, Electrical, Evoked Response |
| Regulation | 21 CFR 882.1870 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
Classification Rationale
Class II (performance standards).
Cleared Devices (139)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | Jan 11, 2026 | SESE |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | Jan 22, 2025 | SESE |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | Dec 12, 2024 | SESE |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | Nov 5, 2024 | SESE |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | Apr 19, 2024 | SESE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | Mar 25, 2024 | SESE |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | Oct 27, 2023 | SESE |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | Aug 17, 2023 | SESE |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | Mar 9, 2022 | SESE |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | Jan 7, 2022 | SESE |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | Aug 13, 2021 | SESE |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | May 22, 2021 | SESE |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | Oct 28, 2020 | SESE |
| K182542 | The EPAD 2 System | Safeop Surgical, Inc. | Feb 22, 2019 | SESE |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | Apr 5, 2017 | SESE |
| K162873 | MEP Monitor | Tonica Elektronik A/S | Mar 31, 2017 | SESE |
| K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | Mar 2, 2017 | SESE |
| K160280 | MagPro R20 | Tonica Elektronik A/S | May 16, 2016 | SESE |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | Eb Neuro S.P.A. | Aug 19, 2015 | SESE |
| K142624 | Neuromaster G1 MEE200 | Nihon Kohden Corporation | Apr 24, 2015 | SESE |
| K132616 | EPAD | Safeop Surgical, Inc. | Jan 24, 2014 | SESE |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | The Magstim Company , Ltd. | Aug 23, 2013 | SESE |
| K123843 | NEUROEPG SYSTEM | Strohl Medical Technologies | Jun 5, 2013 | SESE |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | Natus Neurology Incorporated | May 2, 2013 | SESE |
| K120397 | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM | Nihon Kohden Corp. | Sep 19, 2012 | SESE |
| K112881 | NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) | Nexstim OY | May 22, 2012 | SESE |
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | Apr 25, 2012 | SESE |
| K112052 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | Mar 15, 2012 | SESE |
| K111647 | C2 NERVEMONITOR SYSTEM WITH ACCESSORIES | Inomed Medizintechnik GmbH | Oct 6, 2011 | SESE |
| K110140 | NEUROVISION NERVE LOCATOR MONITOR | Neurovision Medical Products, Inc. | Sep 30, 2011 | SESE |
| K093304 | PROTEKTOR 32 | Natus Medical, Inc. | Aug 11, 2010 | SESE |
| K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE | Nuvasive, Inc. | May 14, 2010 | SESE |
| K091940 | MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION | Tonica Elektronik A/S | Mar 26, 2010 | SESE |
| K091457 | NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM | Nexstim OY | Dec 8, 2009 | SESE |
| K083371 | NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) | Natus Medical, Inc. | Dec 8, 2009 | SESE |
| K090298 | NUVASIVE NEURO VISION SYSTEM | Nuvasive, Inc. | Jun 8, 2009 | SESE |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | Laborie Medical Technologies, Inc. | Mar 6, 2009 | SESE |
| K083124 | NIM 3.0 | Medtronic Xomed, Inc. | Feb 27, 2009 | SESE |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | The Magstim Company , Ltd. | Dec 8, 2008 | SESE |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | Nihon Kohden America, Inc. | Oct 6, 2008 | SESE |
| K072343 | NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Oct 29, 2007 | SESE |
| K071821 | COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 | Tonica Elektronik A/S | Jul 27, 2007 | SESE |
| K062765 | MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Jan 24, 2007 | SESE |
| K061639 | ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON | Axon Systems, Inc. | Nov 1, 2006 | SESE |
| K061645 | MAGPRO, MODEL R30 | Tonica Elektronik A/S | Oct 31, 2006 | SESE |
| K060847 | MAGSTIM 200-2 | Magstim Company Us, LLC | Sep 26, 2006 | SESE |
| K061113 | ORTHOMON | Axon Systems, Inc. | May 23, 2006 | SESE |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | The Magstim Company , Ltd. | Dec 21, 2005 | SESE |
| K051357 | DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH | Digitimer , Ltd. | Sep 20, 2005 | SESE |
| K051178 | MEE-1000A NEUROMASTER | Nihon Kohden America, Inc. | Aug 17, 2005 | SESE |
| K050798 | ECLIPSE NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | Aug 15, 2005 | SESE |
| K051384 | MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM | Nuvasive, Inc. | Jul 11, 2005 | SESE |
| K030526 | PEDIGUARD NERVE DETECTOR SYSTEM | Spine Vision, Inc. | Dec 29, 2004 | SESE |
| K042350 | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR | Cadwell Laboratories, Inc. | Nov 3, 2004 | SESE |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | Excel Tech. , Ltd. | Aug 6, 2004 | SESE |
| K031930 | HIGH SPEED EMG MODULE | Medical Measurement Systems B.V. | Mar 3, 2004 | SESE |
| K032741 | EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | Dec 16, 2003 | SESE |
| K020400 | DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR | Meps, LLC | Aug 23, 2002 | SESE |
| K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) | Excel Tech. , Ltd. | Apr 2, 2001 | SESE |
| K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) | Excel Tech. , Ltd. | Mar 26, 2001 | SESE |
| K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP | Excel Tech. , Ltd. | Mar 19, 2001 | SESE |
| K002969 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 | Xltek | Dec 8, 2000 | SESE |
| K002773 | NEUROMAP WITH NEURO 100 | Radionics, Inc. | Oct 23, 2000 | SESE |
| K000963 | DA VINCHI EEG AND EMG/EP SYSTEMS | Airsep Corp. | Oct 20, 2000 | SESE |
| K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 | Excel Tech. , Ltd. | Jun 30, 2000 | SESE |
| K992911 | MAGSTIM RAPID | Magstim Corporation US | Jan 7, 2000 | SESE |
| K991899 | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES | Nihon Kohden America, Inc. | Sep 1, 1999 | SESE |
| K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 | Excel Tech. , Ltd. | Aug 19, 1999 | SESE |
| K981405 | SYNERGY LT | Oxford Instruments, Plc. | Jul 16, 1998 | SESE |
| K980866 | MEDI-DX 7000 CPT WITH AMREX ELECTRODES | Neuro-Diagnostic Assoc. | May 20, 1998 | SESE |
| K971740 | AMPLAID MK12 | Amplifon S.P.A. | Mar 16, 1998 | SESE |
| K972959 | AMPLAID MK22 | Amplifon S.P.A. | Feb 6, 1998 | SESE |
| K971819 | EPOCH 2000 NEUROLOGICAL WORKSTATION | Axon Systems, Inc. | Nov 20, 1997 | SESE |
| K965065 | TECA. MILLENNIUM | Medelec , Ltd. | Jun 20, 1997 | SESE |
| K963662 | GALILEO EVOKED POTENTIALRE | Biosound, Inc. | Feb 26, 1997 | SESE |
| K962458 | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | Jan 13, 1997 | SESE |
| K962457 | TWO-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | Jan 13, 1997 | SESE |
| K962455 | FOUR-CHANNEL PREAMPLIFIER | Cadwell Laboratories, Inc. | Jan 13, 1997 | SESE |
| K932994 | EVOKED POTENTIAL SYSTEM-1.0 | Neuromedical Systems, Inc. | Apr 15, 1996 | SESE |
| K960170 | ELECTROENCEPHALOGRAPH (EEG) | Moberg Medical, Inc. | Mar 1, 1996 | SESE |
| K955257 | SS102 DUAL CHANNEL SEP STIMULATOR | Axon Systems, Inc. | Feb 2, 1996 | SESE |
| K952294 | NEURONET | Computational Diagnostics, Inc. | Jan 26, 1996 | SESE |
| K944547 | DANTEC KEYPOINT | Mckenna & Cuneo | Sep 19, 1995 | SESE |
| K950208 | NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM | Nihon Kohden America, Inc. | May 10, 1995 | SESE |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | Dantec Medical, Inc. | Nov 9, 1993 | SESE |
| K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | Dantec Medical, Inc. | Aug 31, 1993 | SESE |
| K931428 | CADWELL 6200 A | Cadwell Laboratories, Inc. | Jun 22, 1993 | SESE |
| K924723 | CADWELL SIERRA | Cadwell Laboratories, Inc. | Mar 23, 1993 | SESE |
| K924127 | DANTEC EVOLUTION | Dantec Medical, Inc. | Mar 10, 1993 | SESE |
| K923303 | SAPPHIRE PREMIERE | Medelec , Ltd. | Nov 24, 1992 | SESE |
| K923315 | NICOLET ARK SYSTEM | Nicolet Instrument Corp. | Nov 23, 1992 | SESE |
| K912685 | MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS | Nihon Kohden America, Inc. | Feb 26, 1992 | SESE |
| K915652 | NICOLET PORATBLE SPIRIT SYSTEM | Nicolet Instrument Corp. | Feb 7, 1992 | SESE |
| K912775 | SAPPHIRE 4ME EMG/EP SYSTEM | Medelec Intl. Corp. | Nov 8, 1991 | SESE |
| K905059 | HIGH SPEED MAGNETIC STIMULATOR | Cadwell Laboratories, Inc. | Sep 18, 1991 | SESE |
| K902607 | DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) | Dantec Medical, Inc. | May 14, 1991 | SESE |
| K903731 | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME | Teca, Inc. | Feb 4, 1991 | SESE |
| K894560 | QSI 9000 | Quantified Signal Imaging, Inc. | Aug 8, 1990 | SESE |
| K900482 | SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG | Axon Systems, Inc. | Jun 20, 1990 | SESE |
| K896567 | CANTATA EMG/EVOKED RESPONSE SYSTEM | Dantec Medical, Inc. | Feb 16, 1990 | SESE |
| K894608 | MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM | Micro-Shev , Ltd. | Dec 29, 1989 | SESE |
| K890274 | MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR | Nihon Kohden America, Inc. | May 18, 1989 | SESE |
| K885246 | ADVANTAGE | Clark Davis Medical Systems, Inc. | Feb 27, 1989 | SESE |
| K884870 | TECA/MEDELEC 'CONCEPT' P420 | Teca, Inc. | Feb 23, 1989 | SESE |
| K883340 | NEURAL MAGNETIC STIMULATOR, THE D190 | Tracor Northern, Inc. | Dec 29, 1988 | SESE |
| K881915 | DANTEC MAGNETIC STIMULATOR | Dantec Electronics, Inc. | Oct 17, 1988 | SESE |
| K880088 | CADWELL EXCEL | Cadwell Laboratories, Inc. | May 4, 1988 | SESE |
| K870567 | EVOPORT 300 | Dantec Electronics, Inc. | Oct 6, 1987 | SESE |
| K871964 | SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU. | Siegen Corp. | Oct 1, 1987 | SESE |
| K872106 | DANTEC COUNTERPOINT | Dantec Electronics, Inc. | Sep 10, 1987 | SESE |
| K871338 | NOVAMETRIX MODEL 200 MAGSTIM | Novametrix Medical Systems, Inc. | Aug 4, 1987 | SESE |
| K863175 | EES 10 ELECTRODELESS ELECTRICAL STIMULATOR | Cadwell Laboratories, Inc. | Jan 13, 1987 | SESE |
| K862690 | TRAVELER LT | Bio-Logic Systems Corp. | Nov 25, 1986 | SESE |
| K861900 | LIFESCAN EVOKED POTENTIAL SYSTEM | Neurometrics | Aug 25, 1986 | SESE |
| K860968 | TM-3400, NOMAD (MODIFIED) | Tracor Northern, Inc. | Aug 18, 1986 | SESE |
| K855232 | SOMATOSENSORY EVOKED POTENTIAL STIMULATOR | Neuroscience, Inc. | Jul 3, 1986 | SESE |
| K860903 | TM-3600 A NEURODIAGNOSTIC SYSTEM | Tracor Northern, Inc. | Jun 5, 1986 | SESE |
| K860240 | CNS-EP SYSTEM AND EP 1.0 SOFTWARE | Cns, Inc. | Apr 17, 1986 | SESE |
| K851300 | NEUROPACK 8, MEE-4108 | Nihon Kohden America, Inc. | Jun 13, 1985 | SESE |
| K844992 | BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM | Bio-Logic Systems Corp. | Jun 7, 1985 | SESE |
| K850109 | NOMAD TM-3400 | Tracor Northern, Inc. | Jun 4, 1985 | SESE |
| K843815 | EVOMATIC 8000/4000 | Dantec Electronics, Inc. | May 31, 1985 | SESE |
| K844707 | QUANTUM 84 | Cadwell Laboratories, Inc. | May 21, 1985 | SESE |
| K843712 | AUDIT TM V | Axonics, Inc. | Apr 5, 1985 | SESE |
| K842543 | EVOKED POTENTIAL SYS | Bio-Logic Systems Corp. | Nov 29, 1984 | SESE |
| K843464 | SIEGEN NEUROSCOPE | Siegen Corp. | Nov 20, 1984 | SESE |
| K843253 | EMG/NCV & EVOKED RESPONSE, DESIGN W/ | Neurodiagnostics, Inc. | Nov 20, 1984 | SESE |
| K831896 | COMPACT FOUR | Nicolet Biomedical Instruments | Jul 28, 1983 | SESE |
| K830771 | CADWELL 8400 | Cadwell Laboratories, Inc. | Apr 12, 1983 | SESE |
| K822744 | #ST10 PROGR. EVOKED RESPONSE STIMULATOR | Teca, Inc. | Nov 3, 1982 | SESE |
| K822396 | THE 3500 | Tracor Northern, Inc. | Sep 24, 1982 | SESE |
| K822214 | CADWELL 7400 | Cadwell Laboratories, Inc. | Sep 24, 1982 | SESE |
| K820908 | TECA MODEL SENSOR ER 94 | Teca, Inc. | May 3, 1982 | SESE |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | Lkc Technologies, Inc. | Mar 4, 1982 | SESE |
| K811848 | MODEL SIX BEAM SYSTEM | Braintech, Inc. | Sep 8, 1981 | SESE |
| K810482 | SOMATOSENSORY STIMULATOR | Amplaid USA, Inc. | Apr 29, 1981 | SESE |
| K810560 | TN-3000 EVOKED RESPONSE SYSTEM | Tracor Northern, Inc. | Mar 17, 1981 | SESE |
| K781704 | STIMULATOR, TN-3001 SOMATOSENSORY | Tracor Instruments, Inc. | Dec 1, 1978 | SESE |
| K780539 | STIMULATOR MODEL 8021 | Life-Tech Instruments, Inc. | Jun 22, 1978 | SESE |
Top Applicants
- Cadwell Laboratories, Inc. — 12 clearances
- Nihon Kohden America, Inc. — 7 clearances
- Axon Systems, Inc. — 7 clearances
- Tracor Northern, Inc. — 6 clearances
- Excel Tech. , Ltd. — 6 clearances
