JXEClass II
Device, Nerve Conduction Velocity Measurement
21 CFR 882.1550 / Neurology
JXE is the FDA product code for Device, Nerve Conduction Velocity Measurement, a class II device type, regulated under 21 CFR 882.1550. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JXE
- Device name
- Device, Nerve Conduction Velocity Measurement
- Regulation
- 21 CFR 882.1550
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 27
- Ingested recalls
- 1
Clearances, product code JXE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1982 | 1 |
| 1985 | 3 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2019 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code JXE| Applicant | Clearances |
|---|---|
| Neurometrix, Inc. | 7 |
| Chalgren Enterprises, Inc. | 2 |
| Neurotron Medical | 2 |
| Bak Electronics | 1 |
| Cadwell Laboratories, Inc. | 1 |
| Excel Tech., Ltd. | 1 |
| Grass Instrument Co. | 1 |
| Impulse Systems, Inc. | 1 |
| Insight Medical Corp. | 1 |
| Insta Nerve Canada, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.