Product Code: JXE FDA class 2 21 CFR 882.1550

Device, Nerve Conduction Velocity Measurement

Neurology

Device, Nerve Conduction Velocity Measurement is a neurological diagnostic device used to assess the speed at which electrical signals travel along peripheral nerves, supporting the evaluation of conditions such as peripheral neuropathy, carpal tunnel syndrome, and Guillain-Barre syndrome. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXE, regulated under 21 CFR 882.1550, and falls within the Neurology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JXE
Device Class: FDA class 2
Regulation Number: 882.1550
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240189	NM-01/CPT neurometer (NM-01/CPT)	Mar 26, 2025	Substantially Equivalent	Mde Orvosbiológiai Kutató, Fejleszto,
K190536	Mediracer NCS	Sep 25, 2019	Substantially Equivalent	Mediracer OY
K070109	NEUROMETRIX ADVANCE	Apr 25, 2008	Substantially Equivalent	Neurometrix, Inc.
K060584	NC-STAT	Jul 31, 2006	Substantially Equivalent	Neurometrix, Inc.
K053058	XLTEK NEUROPATH, MODEL PK1070	Feb 07, 2006	Substantially Equivalent	Excel Tech. , Ltd.
K052904	VIRTUAL MEDICAL SYSTEMS MODEL VT3000	Oct 27, 2005	Substantially Equivalent	Scientific Imaging, Inc.
K041320	MODIFICATION TO NC-STAT	Aug 12, 2004	Substantially Equivalent	Neurometrix, Inc.
K013459	MODIFICATION OF NC-STAT	Jan 17, 2002	Substantially Equivalent	Neurometrix, Inc.
K012069	MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT	Aug 01, 2001	Substantially Equivalent	Neurotron Medical, Inc.
K003508	NC-STAT	Jan 17, 2001	Substantially Equivalent	Neurometrix, Inc.
K001692	NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8	Nov 24, 2000	Substantially Equivalent	Neurosoft, Inc.
K000565	MODIFICATION TO NC-STAT	Jun 27, 2000	Substantially Equivalent	Neurometrix, Inc.
K982359	NC-STAT	Oct 02, 1998	Substantially Equivalent	Neurometrix, Inc.
K963208	NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS)	Jul 14, 1997	Substantially Equivalent	Neurotron Medical
K935298	INSTA-NERVE(TM) NERVE CONDUCTION MONITOR	Aug 03, 1994	Substantially Equivalent	Insta Nerve Canada, Inc.
K935017	TD50 ELECTROMYOGRAPH	Jul 28, 1994	Substantially Equivalent	Medelec Intl. Corp.
K932533	SMARTSCOPE	Mar 31, 1994	Substantially Equivalent	Insight Medical Corp.
K923665	REUSABLE DUAL DISC BAR RECORDING ELECTRODES	Oct 05, 1992	Substantially Equivalent	Chalgren Enterprises, Inc.
K921504	REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS	Sep 11, 1992	Substantially Equivalent	Chalgren Enterprises, Inc.
K904165	SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT	May 28, 1991	Substantially Equivalent	Occupational Preventive Diagnostics, Inc.
K900378	EMG OPTION FOR MICROSHEV 4000	Apr 10, 1990	Substantially Equivalent	Micro-Shev , Ltd.
K884663	IMPULSE EPIDURAL ELECTRODE	Jan 17, 1989	Substantially Equivalent	Impulse Systems, Inc.
K843924	DIGITAL ELECTRONEUROMETER S-100	Mar 12, 1985	Substantially Equivalent	Neurotron, Inc.
K844681	EMG REPORT GENERATOR	Feb 26, 1985	Substantially Equivalent	Microsystem Controls
K844216	GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR	Jan 18, 1985	Substantially Equivalent	Grass Instrument Co.
K820031	CADWELL 5200	Feb 04, 1982	Substantially Equivalent	Cadwell Laboratories, Inc.
K760689	NERVEL-NERVE CONDUCTION VELOCITY METER	Oct 05, 1976	Substantially Equivalent	Bak Electronics