Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1550](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1550) → JXE — Device, Nerve Conduction Velocity Measurement

# JXE · Device, Nerve Conduction Velocity Measurement

_Neurology · 21 CFR 882.1550 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE

## Overview

- **Product Code:** JXE
- **Device Name:** Device, Nerve Conduction Velocity Measurement
- **Regulation:** [21 CFR 882.1550](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1550)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 27)

Showing 20 most recent of 27 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240189](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K240189.md) | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | Mar 26, 2025 | SESE |
| [K190536](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K190536.md) | Mediracer NCS | Mediracer OY | Sep 25, 2019 | SESE |
| [K070109](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K070109.md) | NEUROMETRIX ADVANCE | Neurometrix, Inc. | Apr 25, 2008 | SESE |
| [K060584](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K060584.md) | NC-STAT | Neurometrix, Inc. | Jul 31, 2006 | SESE |
| [K053058](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K053058.md) | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | Feb 7, 2006 | SESE |
| [K052904](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K052904.md) | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | Scientific Imaging, Inc. | Oct 27, 2005 | SESE |
| [K041320](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K041320.md) | MODIFICATION TO NC-STAT | Neurometrix, Inc. | Aug 12, 2004 | SESE |
| [K013459](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K013459.md) | MODIFICATION OF NC-STAT | Neurometrix, Inc. | Jan 17, 2002 | SESE |
| [K012069](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K012069.md) | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | Neurotron Medical, Inc. | Aug 1, 2001 | SESE |
| [K003508](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K003508.md) | NC-STAT | Neurometrix, Inc. | Jan 17, 2001 | SESE |
| [K001692](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K001692.md) | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | Nov 24, 2000 | SESE |
| [K000565](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K000565.md) | MODIFICATION TO NC-STAT | Neurometrix, Inc. | Jun 27, 2000 | SESE |
| [K982359](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K982359.md) | NC-STAT | Neurometrix, Inc. | Oct 2, 1998 | SESE |
| [K963208](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K963208.md) | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | Neurotron Medical | Jul 14, 1997 | SESE |
| [K935298](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K935298.md) | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | Insta Nerve Canada, Inc. | Aug 3, 1994 | SESE |
| [K935017](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K935017.md) | TD50 ELECTROMYOGRAPH | Medelec Intl. Corp. | Jul 28, 1994 | SESE |
| [K932533](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K932533.md) | SMARTSCOPE | Insight Medical Corp. | Mar 31, 1994 | SESE |
| [K923665](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K923665.md) | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | Chalgren Enterprises, Inc. | Oct 5, 1992 | SESE |
| [K921504](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K921504.md) | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | Chalgren Enterprises, Inc. | Sep 11, 1992 | SESE |
| [K904165](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE/K904165.md) | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT | Occupational Preventive Diagnostics, Inc. | May 28, 1991 | SESE |

## Top Applicants

- Neurometrix, Inc. — 7 clearances
- Chalgren Enterprises, Inc. — 2 clearances
- Bak Electronics — 1 clearance
- Cadwell Laboratories, Inc. — 1 clearance
- Excel Tech. , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/JXE)

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