Atlas FDA

JXE

27 FDA 510(k) clearances · Product code

99 daysmedian time to decision
332 days90th percentile
27clearances measured

FDA profile

Official device name
Device, Nerve Conduction Velocity Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1550
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 2 · 2007: 2 · 2009: 3 · 2011: 5 · 2012: 6 · 2017: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
NM-01/CPT neurometer (NM-01/CPT) (K240189)Mde Orvosbiológiai Kutató, Fejleszto,2025-03-26
Mediracer NCS (K190536)Mediracer OY2019-09-25
NEUROMETRIX ADVANCE (K070109)Neurometrix, Inc.2008-04-25
NC-STAT (K060584)Neurometrix, Inc.2006-07-31
XLTEK NEUROPATH, MODEL PK1070 (K053058)Excel Tech. , Ltd.2006-02-07
VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (K052904)Scientific Imaging, Inc.2005-10-27
MODIFICATION TO NC-STAT (K041320)Neurometrix, Inc.2004-08-12
MODIFICATION OF NC-STAT (K013459)Neurometrix, Inc.2002-01-17
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (K012069)Neurotron Medical, Inc.2001-08-01
NC-STAT (K003508)Neurometrix, Inc.2001-01-17
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (K001692)Neurosoft, Inc.2000-11-24
MODIFICATION TO NC-STAT (K000565)Neurometrix, Inc.2000-06-27
NC-STAT (K982359)Neurometrix, Inc.1998-10-02
NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) (K963208)Neurotron Medical1997-07-14
INSTA-NERVE(TM) NERVE CONDUCTION MONITOR (K935298)Insta Nerve Canada, Inc.1994-08-03
TD50 ELECTROMYOGRAPH (K935017)Medelec Intl. Corp.1994-07-28
SMARTSCOPE (K932533)Insight Medical Corp.1994-03-31
REUSABLE DUAL DISC BAR RECORDING ELECTRODES (K923665)Chalgren Enterprises, Inc.1992-10-05
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS (K921504)Chalgren Enterprises, Inc.1992-09-11
SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT (K904165)Occupational Preventive Diagnostics, Inc.1991-05-28
EMG OPTION FOR MICROSHEV 4000 (K900378)Micro-Shev , Ltd.1990-04-10
IMPULSE EPIDURAL ELECTRODE (K884663)Impulse Systems, Inc.1989-01-17
DIGITAL ELECTRONEUROMETER S-100 (K843924)Neurotron, Inc.1985-03-12
EMG REPORT GENERATOR (K844681)Microsystem Controls1985-02-26
GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR (K844216)Grass Instrument Co.1985-01-18
CADWELL 5200 (K820031)Cadwell Laboratories, Inc.1982-02-04
NERVEL-NERVE CONDUCTION VELOCITY METER (K760689)Bak Electronics1976-10-05

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Every clearance here is in the API, with alerts when new ones post.