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).
Recent Cleared Devices (20 of 139)
Showing 20 most recent of 139 cleared devices.
| 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 |
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
