Product code JXE— Neurology
NC-STAT
- Classification name
- Device, Nerve Conduction Velocity Measurement
- Device class
- Class 2
- Regulation
- 21 CFR 882.1550
- Advisory panel
- Neurology
- Total cleared
- 27
- First cleared
- Most recent
Market context for product code JXE
FDA has cleared devices under product code JXE between 1976 and 2025, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2019
- 2008
- 2006
- 2005
- 2004
- 2002
- 2001
- 2000
- 1998
- 1997
- 1994
- 1992
- 1991
- 1990
Top applicants under product code JXE
Recent clearances under product code JXE
- K240189 — NM-01/CPT neurometer (NM-01/CPT)
- K190536 — Mediracer NCS
- K070109 — NEUROMETRIX ADVANCE
- K060584 — NC-STAT
- K053058 — XLTEK NEUROPATH, MODEL PK1070
- K052904 — VIRTUAL MEDICAL SYSTEMS MODEL VT3000
- K041320 — MODIFICATION TO NC-STAT
- K013459 — MODIFICATION OF NC-STAT
- K012069 — MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
- K003508 — NC-STAT
- K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
- K000565 — MODIFICATION TO NC-STAT
- K982359 — NC-STAT
- K963208 — NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)
- K935298 — INSTA-NERVE(TM) NERVE CONDUCTION MONITOR
- K935017 — TD50 ELECTROMYOGRAPH
- K932533 — SMARTSCOPE
- K923665 — REUSABLE DUAL DISC BAR RECORDING ELECTRODES
- K921504 — REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
- K904165 — SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT
- K900378 — EMG OPTION FOR MICROSHEV 4000
- K884663 — IMPULSE EPIDURAL ELECTRODE
- K843924 — DIGITAL ELECTRONEUROMETER S-100
- K844681 — EMG REPORT GENERATOR
- K844216 — GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
- K820031 — CADWELL 5200
- K760689 — NERVEL-NERVE CONDUCTION VELOCITY METER
Data sourced from openFDA. This site is unofficial and independent of the FDA.