FDA.reportPublic FDA data

DPNCheck

Primary DI
00816022023657
Brand
DPNCheck
Company
IMPULSE MEDICAL TECHNOLOGIES, INC.
Model
NC-030
Device description
DPNCheck Device
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JXEDevice, Nerve Conduction Velocity Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041320000MODIFICATION TO NC-STATNeurometrix, Inc.2004-08-12JXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816022023657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816022023657008160220236578160220236570816022023657

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic peripheral nerve electrical stimulation systemAn assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure55 KiloPascal100 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080015502
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816022023664DPNCheckNC-0402026-01-09
00816022023671DPNCheckNC-040-C2026-01-09
00816022023688DPNCheckNC-DP22026-01-09
00816022023695DPNCheckDB-025-Training2026-01-09
00816022023701DPNCheckDB-0502026-01-09
00816022023718DPNCheckDB-050-C2026-01-09
00816022023633The Electrode StorePRO-EE6XPRO-EE6X2024-07-15
00816022020786The Electrode StoreSDN1248SDN12482016-09-24
00816022020793The Electrode StoreSDN1280SDN12802016-09-24
00816022020809The Electrode StoreSDN1248BSDN1248B2016-09-24
00816022021226The Electrode StoreDEN-12SAFDEN-12SAF2016-09-24
00816022021233The Electrode StorePRO-E12SAFPRO-E12SAF2016-09-24
00816022022025The Electrode StorePRO-E3PRO-E32016-09-24
00816022022032The Electrode StorePRO-E5PRO-E52016-09-24
00816022022070The Electrode StorePRO-E4PRO-E42016-09-24
00816022022087The Electrode Store62056620562016-09-24
00816022022094The Electrode Store62057620572016-09-24
00816022022100The Electrode Store0048330048332016-09-24
00816022022117The Electrode StoreOBM00046OBM000462016-09-24
00816022022124The Electrode StorePRO-EYPRO-EY2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816022023664DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023671DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023688DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023695DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023701DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023718DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00887868560880Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560897Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560903Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560910Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560927Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560941Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560958Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00851221006056DPNCheck 2.0NeuroMetrix, Inc.JXE2022-12-20
00851221006575DPNCheck, ChinaNeuroMetrix, Inc.JXE2022-12-20