Product code JXE
- Device name
- Device, Nerve Conduction Velocity Measurement
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1550
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, | 2025-03-26 |
| K190536 | Mediracer NCS | Mediracer OY | 2019-09-25 |
| K070109 | NEUROMETRIX ADVANCE | Neurometrix, Inc. | 2008-04-25 |
| K060584 | NC-STAT | Neurometrix, Inc. | 2006-07-31 |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | 2006-02-07 |
| K052904 | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | Scientific Imaging, Inc. | 2005-10-27 |
| K041320 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | 2004-08-12 |
| K013459 | MODIFICATION OF NC-STAT | Neurometrix, Inc. | 2002-01-17 |
| K012069 | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | Neurotron Medical, Inc. | 2001-08-01 |
| K003508 | NC-STAT | Neurometrix, Inc. | 2001-01-17 |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | 2000-11-24 |
| K000565 | MODIFICATION TO NC-STAT | Neurometrix, Inc. | 2000-06-27 |
| K982359 | NC-STAT | Neurometrix, Inc. | 1998-10-02 |
| K963208 | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | Neurotron Medical | 1997-07-14 |
| K935298 | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | Insta Nerve Canada, Inc. | 1994-08-03 |
| K935017 | TD50 ELECTROMYOGRAPH | Medelec Intl. Corp. | 1994-07-28 |
| K932533 | SMARTSCOPE | Insight Medical Corp. | 1994-03-31 |
| K923665 | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | Chalgren Enterprises, Inc. | 1992-10-05 |
| K921504 | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | Chalgren Enterprises, Inc. | 1992-09-11 |
| K904165 | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT | Occupational Preventive Diagnostics, Inc. | 1991-05-28 |
| K900378 | EMG OPTION FOR MICROSHEV 4000 | Micro-Shev , Ltd. | 1990-04-10 |
| K884663 | IMPULSE EPIDURAL ELECTRODE | Impulse Systems, Inc. | 1989-01-17 |
| K843924 | DIGITAL ELECTRONEUROMETER S-100 | Neurotron, Inc. | 1985-03-12 |
| K844681 | EMG REPORT GENERATOR | Microsystem Controls | 1985-02-26 |
| K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR | Grass Instrument Co. | 1985-01-18 |
| K820031 | CADWELL 5200 | Cadwell Laboratories, Inc. | 1982-02-04 |
| K760689 | NERVEL-NERVE CONDUCTION VELOCITY METER | Bak Electronics | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446900208 | NeMus SYSTEM | EB NEURO SPA | 2019-05-24 |
| 00840067100264 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2019-01-08 |
| 08055765540003 | FREMSLIFE | FREMSLIFE SRL | 2018-01-28 |
| 00840067100288 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100431 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100417 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100400 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100394 | Easy III | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100387 | Easy III | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100370 | Easy III | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100363 | Easy III | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100356 | Sierra Summit/Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100349 | Sierra Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100332 | Sierra Summit/Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100325 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100301 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100295 | Cascade Elite | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100035 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100219 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100202 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100196 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100189 | Cascade Pro | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100172 | Cascade | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100165 | Cascade Pro | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100141 | Sierra Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100134 | Sierra Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100127 | Sierra Summit/Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100110 | Sierra Summit/Ascent | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100103 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |
| 00840067100097 | Sierra Summit | CADWELL INDUSTRIES, INC. | 2016-09-05 |