| Device Type ID | 3729 |
| Device Name | Device, Nerve Conduction Velocity Measurement |
| Regulation Description | Nerve Conduction Velocity Measurement Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JXE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3729 |
| Device | Device, Nerve Conduction Velocity Measurement |
| Product Code | JXE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nerve Conduction Velocity Measurement Device. |
| CFR Regulation Number | 882.1550 [🔎] |
| Device Problems | |
|---|---|
Fracture | 9 |
Device Displays Incorrect Message | 6 |
Unexpected Shutdown | 3 |
Noise, Audible | 3 |
No Device Output | 2 |
Failure To Power Up | 2 |
Device Operational Issue | 2 |
Insufficient Information | 1 |
Break | 1 |
Loose Or Intermittent Connection | 1 |
Difficult Or Delayed Activation | 1 |
| Total Device Problems | 31 |