JXE — Device, Nerve Conduction Velocity Measurement Class II
FDA product code JXE covers "Device, Nerve Conduction Velocity Measurement", a Class II medical device regulated under 21 CFR 882.1550. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JXE
- Device Class
- Class II
- Regulation Number
- 882.1550
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240189 | mde orvosbiológiai kutató, fejleszto | NM-01/CPT neurometer (NM-01/CPT) | March 26, 2025 |
| K190536 | mediracer | Mediracer NCS | September 25, 2019 |
| K070109 | neurometrix | NEUROMETRIX ADVANCE | April 25, 2008 |
| K060584 | neurometrix | NC-STAT | July 31, 2006 |
| K053058 | excel tech. | XLTEK NEUROPATH, MODEL PK1070 | February 7, 2006 |
| K052904 | scientific imaging | VIRTUAL MEDICAL SYSTEMS MODEL VT3000 | October 27, 2005 |
| K041320 | neurometrix | MODIFICATION TO NC-STAT | August 12, 2004 |
| K013459 | neurometrix | MODIFICATION OF NC-STAT | January 17, 2002 |
| K012069 | neurotron medical | MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT | August 1, 2001 |
| K003508 | neurometrix | NC-STAT | January 17, 2001 |
| K001692 | neurosoft | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | November 24, 2000 |
| K000565 | neurometrix | MODIFICATION TO NC-STAT | June 27, 2000 |
| K982359 | neurometrix | NC-STAT | October 2, 1998 |
| K963208 | neurotron medical | NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) | July 14, 1997 |
| K935298 | insta nerve canada | INSTA-NERVE(TM) NERVE CONDUCTION MONITOR | August 3, 1994 |
| K935017 | medelec intl | TD50 ELECTROMYOGRAPH | July 28, 1994 |
| K932533 | insight medical | SMARTSCOPE | March 31, 1994 |
| K923665 | chalgren enterprises | REUSABLE DUAL DISC BAR RECORDING ELECTRODES | October 5, 1992 |
| K921504 | chalgren enterprises | REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS | September 11, 1992 |
| K904165 | occupational preventive diagnostics | SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT | May 28, 1991 |