FDA.reportPublic FDA data

WAVi Scan Kit

Primary DI
B592WK200
Brand
WAVi Scan Kit
Company
WAVI CO.
Model
WK200
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response
GWQFull-Montage Standard Electroencephalograph
GXYElectrode, Cutaneous
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
GXYElectrode, CutaneousNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162460000
K213900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162460000WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode ContactsWavi Co.2017-04-28GXY
K213900000WAVi SCAN EEG System and AccessoriesWavi Co.2022-05-06GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B592WK200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
007785282
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B592SW100WAVi Scan SoftwareSW1002026-03-25
B592WD100WAVi Electrical Processing UnitWD1002026-03-25
B592WH801WAVi Style Ear ClipsWH8012026-03-25
B592WE100WAVi Co.WE1002019-03-11
B592WE200WAVi Co.WE2002019-03-11
B592WH200WAVi CoWH2002019-03-11
B592WH300WAVi Co.WH3002019-03-11
B592WH400WAVi Co.WH4002019-03-11
B592WH500WAVi Co.WH5002019-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05