JXE · Device, Nerve Conduction Velocity Measurement
Neurology · 21 CFR 882.1550 · Class 2
Overview
| Product Code | JXE |
|---|---|
| Device Name | Device, Nerve Conduction Velocity Measurement |
| Regulation | 21 CFR 882.1550 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | Mar 26, 2025 | SESE |
| K190536 | Mediracer NCS | Mediracer OY | Sep 25, 2019 | SESE |
| K070109 | NEUROMETRIX ADVANCE | Neurometrix, Inc. | Apr 25, 2008 | SESE |
| K060584 | NC-STAT | Neurometrix, Inc. | Jul 31, 2006 | SESE |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | Feb 7, 2006 | SESE |
| K052904 | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | Scientific Imaging, Inc. | Oct 27, 2005 | SESE |
| K041320 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | Aug 12, 2004 | SESE |
| K013459 | MODIFICATION OF NC-STAT | Neurometrix, Inc. | Jan 17, 2002 | SESE |
| K012069 | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | Neurotron Medical, Inc. | Aug 1, 2001 | SESE |
| K003508 | NC-STAT | Neurometrix, Inc. | Jan 17, 2001 | SESE |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | Nov 24, 2000 | SESE |
| K000565 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | Jun 27, 2000 | SESE |
| K982359 | NC-STAT | Neurometrix, Inc. | Oct 2, 1998 | SESE |
| K963208 | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | Neurotron Medical | Jul 14, 1997 | SESE |
| K935298 | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | Insta Nerve Canada, Inc. | Aug 3, 1994 | SESE |
| K935017 | TD50 ELECTROMYOGRAPH | Medelec Intl. Corp. | Jul 28, 1994 | SESE |
| K932533 | SMARTSCOPE | Insight Medical Corp. | Mar 31, 1994 | SESE |
| K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | Chalgren Enterprises, Inc. | Oct 5, 1992 | SESE |
| K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | Chalgren Enterprises, Inc. | Sep 11, 1992 | SESE |
| K904165 | 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
