Product Code: GWF FDA class 2 21 CFR 882.1870

Stimulator, Electrical, Evoked Response

Neurology

The Stimulator, Electrical, Evoked Response is a neurological diagnostic device that delivers controlled electrical stimuli to peripheral nerves or sensory receptors to elicit evoked potentials, which are used to evaluate the integrity of sensory pathways in the nervous system. It is an FDA Class 2 device requiring 510(k) premarket notification to demonstrate substantial equivalence. Regulated under 21 CFR 882.1870 with product code GWF in the Neurology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

139

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GWF
Device Class: FDA class 2
Regulation Number: 882.1870
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 139 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252842	SafeOp 3: Neural Informatix System	Jan 11, 2026	Substantially Equivalent	Alphatec Spine, Inc.
K243982	Nicolet EDX	Jan 22, 2025	Substantially Equivalent	Natus Neurology Incorporated
K243495	Natus Ultrapro S100 (982A0594)	Dec 12, 2024	Substantially Equivalent	Natus Neurology Incorporated
K242345	Delphi Stimulator	Nov 05, 2024	Substantially Equivalent	Quantalx Neuroscience
K234092	SafeOp 3: Neural Informatix Systeem	Apr 19, 2024	Substantially Equivalent	Alphatec Spine, Inc.
K234080	MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)	Mar 25, 2024	Substantially Equivalent	Soterix Medical, Inc.
K233292	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	Oct 27, 2023	Substantially Equivalent	Inomed Medizintechnik GmbH
K230415	Cadwell Guardian	Aug 17, 2023	Substantially Equivalent	Cadwell Industries, Inc.
K213849	SafeOp 2: Neural Informatix System	Mar 09, 2022	Substantially Equivalent	Alphatec Spine, Inc.
K212166	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	Jan 07, 2022	Substantially Equivalent	Inomed Medizintechnik GmbH
K192823	MEGA-TMS	Aug 13, 2021	Substantially Equivalent	Soterix Medical, Inc.
K190703	Neuro-IOM system with Neuro-IOM.NET software	May 22, 2021	Substantially Equivalent	Neurosoft , Ltd.
K200759	NIM Vital, Nerve Integrity Monitor	Oct 28, 2020	Substantially Equivalent	Medtronic Xomed, Inc.
K182542	The EPAD 2 System	Feb 22, 2019	Substantially Equivalent	Safeop Surgical, Inc.
K170677	Neurovision Nerve Locator Monitor (Nerveana), EMGView Software	Apr 05, 2017	Substantially Equivalent	Neurovision Medical Product, Inc.
K162873	MEP Monitor	Mar 31, 2017	Substantially Equivalent	Tonica Elektronik A/S
K162199	Cascade IOMAX Intraoperative Monitor	Mar 02, 2017	Substantially Equivalent	Cadwell Industries, Inc.
K160280	MagPro R20	May 16, 2016	Substantially Equivalent	Tonica Elektronik A/S
K150220	STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast	Aug 19, 2015	Substantially Equivalent	Eb Neuro S.P.A.
K142624	Neuromaster G1 MEE200	Apr 24, 2015	Substantially Equivalent	Nihon Kohden Corporation
K132616	EPAD	Jan 24, 2014	Substantially Equivalent	Safeop Surgical, Inc.
K130403	MAGSTIM DOUBLE 70-2 COIL	Aug 23, 2013	Substantially Equivalent	The Magstim Company , Ltd.
K123843	NEUROEPG SYSTEM	Jun 05, 2013	Substantially Equivalent	Strohl Medical Technologies
K130346	SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION	May 02, 2013	Substantially Equivalent	Natus Neurology Incorporated
K120397	MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM	Sep 19, 2012	Substantially Equivalent	Nihon Kohden Corp.
K112881	NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)	May 22, 2012	Substantially Equivalent	Nexstim OY
K120979	CAREFUSION NICOLET EDX	Apr 25, 2012	Substantially Equivalent	Carefusion 209, Inc.
K112052	CAREFUSION NICOLET EDX	Mar 15, 2012	Substantially Equivalent	Carefusion 209, Inc.
K111647	C2 NERVEMONITOR SYSTEM WITH ACCESSORIES	Oct 06, 2011	Substantially Equivalent	Inomed Medizintechnik GmbH
K110140	NEUROVISION NERVE LOCATOR MONITOR	Sep 30, 2011	Substantially Equivalent	Neurovision Medical Products, Inc.
K093304	PROTEKTOR 32	Aug 11, 2010	Substantially Equivalent	Natus Medical, Inc.
K094054	MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE	May 14, 2010	Substantially Equivalent	Nuvasive, Inc.
K091940	MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION	Mar 26, 2010	Substantially Equivalent	Tonica Elektronik A/S
K091457	NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM	Dec 08, 2009	Substantially Equivalent	Nexstim OY
K083371	NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)	Dec 08, 2009	Substantially Equivalent	Natus Medical, Inc.
K090298	NUVASIVE NEURO VISION SYSTEM	Jun 08, 2009	Substantially Equivalent	Nuvasive, Inc.
K082614	EVOX ELECTRO DIAGNOSTIC DEVICE	Mar 06, 2009	Substantially Equivalent	Laborie Medical Technologies, Inc.
K083124	NIM 3.0	Feb 27, 2009	Substantially Equivalent	Medtronic Xomed, Inc.
K080499	MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00	Dec 08, 2008	Substantially Equivalent	The Magstim Company , Ltd.
K071969	SEN-4100 ELECTRIC STIMULATOR	Oct 06, 2008	Substantially Equivalent	Nihon Kohden America, Inc.
K072343	NEUROVISION JJB SYSTEM	Oct 29, 2007	Substantially Equivalent	Nuvasive, Inc.
K071821	COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65	Jul 27, 2007	Substantially Equivalent	Tonica Elektronik A/S
K062765	MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM	Jan 24, 2007	Substantially Equivalent	Nuvasive, Inc.
K061639	ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON	Nov 01, 2006	Substantially Equivalent	Axon Systems, Inc.
K061645	MAGPRO, MODEL R30	Oct 31, 2006	Substantially Equivalent	Tonica Elektronik A/S
K060847	MAGSTIM 200-2	Sep 26, 2006	Substantially Equivalent	Magstim Company Us, LLC
K061113	ORTHOMON	May 23, 2006	Substantially Equivalent	Axon Systems, Inc.
K051864	MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00	Dec 21, 2005	Substantially Equivalent	The Magstim Company , Ltd.
K051357	DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH	Sep 20, 2005	Substantially Equivalent	Digitimer , Ltd.
K051178	MEE-1000A NEUROMASTER	Aug 17, 2005	Substantially Equivalent	Nihon Kohden America, Inc.
K050798	ECLIPSE NEUROLOGICAL WORKSTATION	Aug 15, 2005	Substantially Equivalent	Axon Systems, Inc.
K051384	MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM	Jul 11, 2005	Substantially Equivalent	Nuvasive, Inc.
K030526	PEDIGUARD NERVE DETECTOR SYSTEM	Dec 29, 2004	Substantially Equivalent	Spine Vision, Inc.
K042350	TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR	Nov 03, 2004	Substantially Equivalent	Cadwell Laboratories, Inc.
K040358	XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248	Aug 06, 2004	Substantially Equivalent	Excel Tech. , Ltd.
K031930	HIGH SPEED EMG MODULE	Mar 03, 2004	Substantially Equivalent	Medical Measurement Systems B.V.
K032741	EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION	Dec 16, 2003	Substantially Equivalent	Axon Systems, Inc.
K020400	DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR	Aug 23, 2002	Substantially Equivalent	Meps, LLC
K010092	XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)	Apr 02, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010090	XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)	Mar 26, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K010087	XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP	Mar 19, 2001	Substantially Equivalent	Excel Tech. , Ltd.
K002969	XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8	Dec 08, 2000	Substantially Equivalent	Xltek
K002773	NEUROMAP WITH NEURO 100	Oct 23, 2000	Substantially Equivalent	Radionics, Inc.
K000963	DA VINCHI EEG AND EMG/EP SYSTEMS	Oct 20, 2000	Substantially Equivalent	Airsep Corp.
K001101	XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4	Jun 30, 2000	Substantially Equivalent	Excel Tech. , Ltd.
K992911	MAGSTIM RAPID	Jan 07, 2000	Substantially Equivalent	Magstim Corporation US
K991899	NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES	Sep 01, 1999	Substantially Equivalent	Nihon Kohden America, Inc.
K992313	XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16	Aug 19, 1999	Substantially Equivalent	Excel Tech. , Ltd.
K981405	SYNERGY LT	Jul 16, 1998	Substantially Equivalent	Oxford Instruments, Plc.
K980866	MEDI-DX 7000 CPT WITH AMREX ELECTRODES	May 20, 1998	Substantially Equivalent	Neuro-Diagnostic Assoc.
K971740	AMPLAID MK12	Mar 16, 1998	Substantially Equivalent	Amplifon S.P.A.
K972959	AMPLAID MK22	Feb 06, 1998	Substantially Equivalent	Amplifon S.P.A.
K971819	EPOCH 2000 NEUROLOGICAL WORKSTATION	Nov 20, 1997	Substantially Equivalent	Axon Systems, Inc.
K965065	TECA. MILLENNIUM	Jun 20, 1997	Substantially Equivalent	Medelec , Ltd.
K963662	GALILEO EVOKED POTENTIALRE	Feb 26, 1997	Substantially Equivalent	Biosound, Inc.
K962458	CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER	Jan 13, 1997	Substantially Equivalent	Cadwell Laboratories, Inc.
K962457	TWO-CHANNEL PREAMPLIFIER	Jan 13, 1997	Substantially Equivalent	Cadwell Laboratories, Inc.
K962455	FOUR-CHANNEL PREAMPLIFIER	Jan 13, 1997	Substantially Equivalent	Cadwell Laboratories, Inc.
K932994	EVOKED POTENTIAL SYSTEM-1.0	Apr 15, 1996	Substantially Equivalent	Neuromedical Systems, Inc.
K960170	ELECTROENCEPHALOGRAPH (EEG)	Mar 01, 1996	Substantially Equivalent	Moberg Medical, Inc.
K955257	SS102 DUAL CHANNEL SEP STIMULATOR	Feb 02, 1996	Substantially Equivalent	Axon Systems, Inc.
K952294	NEURONET	Jan 26, 1996	Substantially Equivalent	Computational Diagnostics, Inc.
K944547	DANTEC KEYPOINT	Sep 19, 1995	Substantially Equivalent	Mckenna & Cuneo
K950208	NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM	May 10, 1995	Substantially Equivalent	Nihon Kohden America, Inc.
K931923	DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)	Nov 09, 1993	Substantially Equivalent	Dantec Medical, Inc.
K926516	DANTEC MAGNETIC STIMULATOR MAGPRO	Aug 31, 1993	Substantially Equivalent	Dantec Medical, Inc.
K931428	CADWELL 6200 A	Jun 22, 1993	Substantially Equivalent	Cadwell Laboratories, Inc.
K924723	CADWELL SIERRA	Mar 23, 1993	Substantially Equivalent	Cadwell Laboratories, Inc.
K924127	DANTEC EVOLUTION	Mar 10, 1993	Substantially Equivalent	Dantec Medical, Inc.
K923303	SAPPHIRE PREMIERE	Nov 24, 1992	Substantially Equivalent	Medelec , Ltd.
K923315	NICOLET ARK SYSTEM	Nov 23, 1992	Substantially Equivalent	Nicolet Instrument Corp.
K912685	MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS	Feb 26, 1992	Substantially Equivalent	Nihon Kohden America, Inc.
K915652	NICOLET PORATBLE SPIRIT SYSTEM	Feb 07, 1992	Substantially Equivalent	Nicolet Instrument Corp.
K912775	SAPPHIRE 4ME EMG/EP SYSTEM	Nov 08, 1991	Substantially Equivalent	Medelec Intl. Corp.
K905059	HIGH SPEED MAGNETIC STIMULATOR	Sep 18, 1991	Substantially Equivalent	Cadwell Laboratories, Inc.
K902607	DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)	May 14, 1991	Substantially Equivalent	Dantec Medical, Inc.
K903731	SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME	Feb 04, 1991	Substantially Equivalent	Teca, Inc.
K894560	QSI 9000	Aug 08, 1990	Substantially Equivalent	Quantified Signal Imaging, Inc.
K900482	SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG	Jun 20, 1990	Substantially Equivalent	Axon Systems, Inc.
K896567	CANTATA EMG/EVOKED RESPONSE SYSTEM	Feb 16, 1990	Substantially Equivalent	Dantec Medical, Inc.
K894608	MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM	Dec 29, 1989	Substantially Equivalent	Micro-Shev , Ltd.
K890274	MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR	May 18, 1989	Substantially Equivalent	Nihon Kohden America, Inc.
K885246	ADVANTAGE	Feb 27, 1989	Substantially Equivalent	Clark Davis Medical Systems, Inc.
K884870	TECA/MEDELEC 'CONCEPT' P420	Feb 23, 1989	Substantially Equivalent	Teca, Inc.
K883340	NEURAL MAGNETIC STIMULATOR, THE D190	Dec 29, 1988	Substantially Equivalent	Tracor Northern, Inc.
K881915	DANTEC MAGNETIC STIMULATOR	Oct 17, 1988	Substantially Equivalent	Dantec Electronics, Inc.
K880088	CADWELL EXCEL	May 04, 1988	Substantially Equivalent	Cadwell Laboratories, Inc.
K870567	EVOPORT 300	Oct 06, 1987	Substantially Equivalent	Dantec Electronics, Inc.
K871964	SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.	Oct 01, 1987	Substantially Equivalent	Siegen Corp.
K872106	DANTEC COUNTERPOINT	Sep 10, 1987	Substantially Equivalent	Dantec Electronics, Inc.
K871338	NOVAMETRIX MODEL 200 MAGSTIM	Aug 04, 1987	Substantially Equivalent	Novametrix Medical Systems, Inc.
K863175	EES 10 ELECTRODELESS ELECTRICAL STIMULATOR	Jan 13, 1987	Substantially Equivalent	Cadwell Laboratories, Inc.
K862690	TRAVELER LT	Nov 25, 1986	Substantially Equivalent	Bio-Logic Systems Corp.
K861900	LIFESCAN EVOKED POTENTIAL SYSTEM	Aug 25, 1986	Substantially Equivalent	Neurometrics
K860968	TM-3400, NOMAD (MODIFIED)	Aug 18, 1986	Substantially Equivalent	Tracor Northern, Inc.
K855232	SOMATOSENSORY EVOKED POTENTIAL STIMULATOR	Jul 03, 1986	Substantially Equivalent	Neuroscience, Inc.
K860903	TM-3600 A NEURODIAGNOSTIC SYSTEM	Jun 05, 1986	Substantially Equivalent	Tracor Northern, Inc.
K860240	CNS-EP SYSTEM AND EP 1.0 SOFTWARE	Apr 17, 1986	Substantially Equivalent	Cns, Inc.
K851300	NEUROPACK 8, MEE-4108	Jun 13, 1985	Substantially Equivalent	Nihon Kohden America, Inc.
K844992	BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM	Jun 07, 1985	Substantially Equivalent	Bio-Logic Systems Corp.
K850109	NOMAD TM-3400	Jun 04, 1985	Substantially Equivalent	Tracor Northern, Inc.
K843815	EVOMATIC 8000/4000	May 31, 1985	Substantially Equivalent	Dantec Electronics, Inc.
K844707	QUANTUM 84	May 21, 1985	Substantially Equivalent	Cadwell Laboratories, Inc.
K843712	AUDIT TM V	Apr 05, 1985	Substantially Equivalent	Axonics, Inc.
K842543	EVOKED POTENTIAL SYS	Nov 29, 1984	Substantially Equivalent	Bio-Logic Systems Corp.
K843464	SIEGEN NEUROSCOPE	Nov 20, 1984	Substantially Equivalent	Siegen Corp.
K843253	EMG/NCV & EVOKED RESPONSE, DESIGN W/	Nov 20, 1984	Substantially Equivalent	Neurodiagnostics, Inc.
K831896	COMPACT FOUR	Jul 28, 1983	Substantially Equivalent	Nicolet Biomedical Instruments
K830771	CADWELL 8400	Apr 12, 1983	Substantially Equivalent	Cadwell Laboratories, Inc.
K822744	#ST10 PROGR. EVOKED RESPONSE STIMULATOR	Nov 03, 1982	Substantially Equivalent	Teca, Inc.
K822396	THE 3500	Sep 24, 1982	Substantially Equivalent	Tracor Northern, Inc.
K822214	CADWELL 7400	Sep 24, 1982	Substantially Equivalent	Cadwell Laboratories, Inc.
K820908	TECA MODEL SENSOR ER 94	May 03, 1982	Substantially Equivalent	Teca, Inc.
K820414	UNIVERSAL TESTING & ANALYSIS SYSTEMS	Mar 04, 1982	Substantially Equivalent	Lkc Technologies, Inc.
K811848	MODEL SIX BEAM SYSTEM	Sep 08, 1981	Substantially Equivalent	Braintech, Inc.
K810482	SOMATOSENSORY STIMULATOR	Apr 29, 1981	Substantially Equivalent	Amplaid USA, Inc.
K810560	TN-3000 EVOKED RESPONSE SYSTEM	Mar 17, 1981	Substantially Equivalent	Tracor Northern, Inc.
K781704	STIMULATOR, TN-3001 SOMATOSENSORY	Dec 01, 1978	Substantially Equivalent	Tracor Instruments, Inc.
K780539	STIMULATOR MODEL 8021	Jun 22, 1978	Substantially Equivalent	Life-Tech Instruments, Inc.