FDA.reportPublic FDA data

NA

Primary DI
04582275270020
Brand
NA
Company
KONAN MEDICAL USA, INC.
Model
EV-001
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWEStimulator, photic, evoked response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081591000NEUCODIAVerisci Corporation2009-05-15GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275270020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275270020045822752700204582275270020

GMDN Terms#

Term, Definition table
TermDefinition
Vision electrophysiology analysis systemAn assembly of mains electricity (AC-powered) devices that provides visual stimuli (e.g., patterns of light, images) to a patient to measure, record, and display visual electrophysiologic responses [e.g., electroretinogram (ERG), visual evoked potential (VEP), and electrooculogram (EOG)], typically as an aid in the diagnosis and management of visual disorders involving ocular electrophysiology (EP), e.g., glaucoma. It may involve the use of electrodes placed on the patient's face and eyes, or the use of other devices such as visual stimulation goggles. The system may be used to screen infants and pre-school children for visual disorders without dilation or sedation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788439219
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275270082NACHINREST2025-12-12
04582275270075NAOFA-0012024-08-02
04582275270068NACOLORDX CCT HD2023-06-15
04582275270037NAM339 DME CARBON CL2016-09-23
04582275270044NAM379 DME CARBON R2016-09-23
04582275270051N/AEyekinetix2019-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857901006620RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04