Device, Nerve Conduction Velocity Measurement
FDA product code JXE · Class II (moderate risk) · 21 CFR 882.1550 · Neurology
27510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Neurometrix, Inc. 7
- Neurotron Medical 2
- Chalgren Enterprises, Inc. 2
- Insight Medical Corp. 1
- Mde Orvosbiológiai Kutató, Fejleszto, 1
- Mediracer OY 1
- Excel Tech. , Ltd. 1
- Scientific Imaging, Inc. 1
- Neurosoft, Inc. 1
- Insta Nerve Canada, Inc. 1
- Medelec Intl. Corp. 1
- Bak Electronics 1
- Occupational Preventive Diagnostics, Inc. 1
- Micro-Shev , Ltd. 1
- Impulse Systems, Inc. 1
- Neurotron, Inc. 1
- Microsystem Controls 1
- Grass Instrument Co. 1
- Cadwell Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240189 | NM-01/CPT neurometer (NM-01/CPT)JXE · Traditional | Mde Orvosbiológiai Kutató, Fejleszto, | 03/26/2025SE |
| K190536 | Mediracer NCSJXE · Traditional | Mediracer OY | 09/25/2019SE |
| K070109 | Neurometrix AdvanceJXE · Traditional | Neurometrix, Inc. | 04/25/2008SE |
| K060584 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 07/31/2006SE |
| K053058 | Xltek Neuropath, Model PK1070JXE · Traditional | Excel Tech. , Ltd. | 02/07/2006SE |
| K052904 | Virtual Medical Systems Model VT3000JXE · Traditional | Scientific Imaging, Inc. | 10/27/2005SE |
| K041320 | Modification to Nc-StatJXE · Traditional | Neurometrix, Inc. | 08/12/2004SE |
| K013459 | Modification of Nc-StatJXE · Traditional | Neurometrix, Inc. | 01/17/2002SE |
| K012069 | Modification To:Brevio Nerve Conduction Test InstrumentJXE · Special | Neurotron Medical, Inc. | 08/01/2001SE |
| K003508 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 01/17/2001SE |
| K001692 | Neuro Scan Medical Ststems, Model Medicor 8JXE · Traditional | Neurosoft, Inc. | 11/24/2000SE |
| K000565 | Modification to Nc-StatJXE · Traditional | Neurometrix, Inc. | 06/27/2000SE |
| K982359 | Nc-StatJXE · Traditional | Neurometrix, Inc. | 10/02/1998SE |
| K963208 | Nervepace(R) Nerve Conduction Viewscope (200VS)JXE · Traditional | Neurotron Medical | 07/14/1997SE |
| K935298 | Insta-Nerve(Tm) Nerve Conduction MonitorJXE · Traditional | Insta Nerve Canada, Inc. | 08/03/1994SE |
| K935017 | TD50 ElectromyographJXE · Traditional | Medelec Intl. Corp. | 07/28/1994SE |
| K932533 | SmartscopeJXE · Traditional | Insight Medical Corp. | 03/31/1994SE |
| K923665 | Reusable Dual Disc Bar Recording ElectrodesJXE · Traditional | Chalgren Enterprises, Inc. | 10/05/1992SE |
| K921504 | Reusable Dual Disc Bar Electrodes, Various ModelsJXE · Traditional | Chalgren Enterprises, Inc. | 09/11/1992SE |
| K904165 | Sensory Nerve Conduction Velocity Testing UnitJXE · Traditional | Occupational Preventive Diagnostics, Inc. | 05/28/1991SE |
| K900378 | Emg Option for Microshev 4000JXE · Traditional | Micro-Shev , Ltd. | 04/10/1990SE |
| K884663 | Impulse Epidural ElectrodeJXE · Traditional | Impulse Systems, Inc. | 01/17/1989SE |
| K843924 | Digital Electroneurometer S-100JXE · Traditional | Neurotron, Inc. | 03/12/1985SE |
| K844681 | Emg Report GeneratorJXE · Traditional | Microsystem Controls | 02/26/1985SE |
| K844216 | Grass Model NL Facial Nerve Locator & MonitorJXE · Traditional | Grass Instrument Co. | 01/18/1985SE |
| K820031 | Cadwell 5200JXE · Traditional | Cadwell Laboratories, Inc. | 02/04/1982SE |
| K760689 | Nervel-Nerve Conduction Velocity MeterJXE · Traditional | Bak Electronics | 10/05/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1521-2012 | Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single…Incorrect product picture label was on the product box. | Biomet, Inc. | 04/18/2012Terminated |