Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1870](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1870) → GWF — Stimulator, Electrical, Evoked Response # GWF · Stimulator, Electrical, Evoked Response _Neurology · 21 CFR 882.1870 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF ## Overview - **Product Code:** GWF - **Device Name:** Stimulator, Electrical, Evoked Response - **Regulation:** [21 CFR 882.1870](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1870) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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). ## Recent Cleared Devices (20 of 139) Showing 20 most recent of 139 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252842](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K252842.md) | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | Jan 11, 2026 | SESE | | [K243982](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K243982.md) | Nicolet EDX | Natus Neurology Incorporated | Jan 22, 2025 | SESE | | [K243495](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K243495.md) | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | Dec 12, 2024 | SESE | | [K242345](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K242345.md) | Delphi Stimulator | Quantalx Neuroscience | Nov 5, 2024 | SESE | | [K234092](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K234092.md) | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | Apr 19, 2024 | SESE | | [K234080](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K234080.md) | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | Mar 25, 2024 | SESE | | [K233292](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K233292.md) | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | Oct 27, 2023 | SESE | | [K230415](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K230415.md) | Cadwell Guardian | Cadwell Industries, Inc. | Aug 17, 2023 | SESE | | [K213849](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K213849.md) | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | Mar 9, 2022 | SESE | | [K212166](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K212166.md) | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | Jan 7, 2022 | SESE | | [K192823](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K192823.md) | MEGA-TMS | Soterix Medical, Inc. | Aug 13, 2021 | SESE | | [K190703](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K190703.md) | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | May 22, 2021 | SESE | | [K200759](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K200759.md) | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | Oct 28, 2020 | SESE | | [K182542](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K182542.md) | The EPAD 2 System | Safeop Surgical, Inc. | Feb 22, 2019 | SESE | | [K170677](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K170677.md) | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | Apr 5, 2017 | SESE | | [K162873](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K162873.md) | MEP Monitor | Tonica Elektronik A/S | Mar 31, 2017 | SESE | | [K162199](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K162199.md) | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | Mar 2, 2017 | SESE | | [K160280](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K160280.md) | MagPro R20 | Tonica Elektronik A/S | May 16, 2016 | SESE | | [K150220](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K150220.md) | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | Eb Neuro S.P.A. | Aug 19, 2015 | SESE | | [K142624](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF/K142624.md) | Neuromaster G1 MEE200 | Nihon Kohden Corporation | Apr 24, 2015 | SESE | ## Top Applicants - Cadwell Laboratories, Inc. — 12 clearances - Axon Systems, Inc. — 7 clearances - Nihon Kohden America, Inc. — 7 clearances - Excel Tech. , Ltd. — 6 clearances - Tracor Northern, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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