Neurometer®

Primary DI
00860012496600
Brand
Neurometer®
Company
NEUROTRON, INC.
Model
CPT/C
Device description
Neurometer® CPT/C® electrodiagnostic devices provide painless, automated neuro-selective evaluations of both myelinated and unmyelinated fiber function. These assessments help map neuropathies, radiculopathies, and other sensory pathologies while detecting both painless and painful impairments, as well as subclinical nerve dysfunction. More than 30 years after leaving the laboratory for clinical applications ranging from Podiatry to Neurology and dozens of other specialties in-between, the Neurometer® evaluation continues to provide unique diagnostic measures of sensory nerve conduction thresholds (sNCT™s). The most widely used sNCT™ measure is Current Perception Threshold (CPT® ) which is the minimum amount of painless neuroselective electrical stimulus that consistently elicits a nerve response. The Neurometer generates a constant current stimulus by monitoring and compensating for tissue impedance variations. The stimulus evokes responses that quantify the functional integrity of each of the three major sub-populations of sensory nerve fibers. Specifically, A bata, A delta & C fiber groups are selectively stimulated by sinusoid waveform currents of 2000 Hz, 250 Hz and 5 Hz respectively. Using small surface electrodes, this test generates discrete double-blinded CPT measures (p
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLNDevice, Vibration Threshold Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLNDevice, Vibration Threshold MeasurementNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853608000NEUROMETERNeurotron, Inc.1986-06-12LLN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012496600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012496600008600124966008600124966000860012496600

GMDN Terms#

Term, Definition table
TermDefinition
Vibratory biothesiometerAn electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma.

Contacts#

Phone, Email table
PhoneEmail
+1-303-316-0555support@neurotron.com

Regulatory Flags#

DUNS number
131870735
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573224000317PAINVISIONSANYO SEIKO CO.,LTD.LLN2026-05-22
08908022363016NEURO TOUCHYOSTRA LABS PRIVATE LIMITEDLLN2024-01-10
00702173355696CASEWR MEDICAL ELECTRONICS CO INCLLN2016-08-29