FDA.reportPublic FDA data

NExT-HS

Primary DI
08056446901137
Brand
NExT-HS
Company
EB NEURO SPA
Model
B9700108000
Device description
Hand-held electric stimulation probe
Published
2025-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response
GWFStimulator, Electrical, Evoked Response
GWJStimulator, Auditory, Evoked Response
GWLAmplifier, Physiological Signal
IKNElectromyograph, Diagnostic
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWLAmplifier, Physiological SignalNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242832000NExT Station; NExT Station AdvancedEb Neuro S.P.A.2024-12-12GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056446901137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446901137080564469011378056446901137

GMDN Terms#

Term, Definition table
TermDefinition
ElectromyographAn electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.

Contacts#

Phone, Email table
PhoneEmail
+390554565111info@ebneuro.com

Regulatory Flags#

DUNS number
339182263
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056446900338NeMus 2 600B98000666012025-05-26
08056446900345NeMus 2 700B98000667012025-05-26
08056446900352NeMus 2 +B98000668012025-05-26
08056446901038GOGGLES STIMULATOR IIB97000910002025-05-22
08056446901106NExT-DOCKINGB97000960002025-05-22
08056446901113NExT-PADB97000960102025-05-22
08056446901120NExT-AMP-ADVANCEDB96300960052025-05-22
08056446901168NExT-AMPB96300960022025-05-22
08056446901199NExT-ASB91090001412025-05-22
08056446901205NExT StationB98000960012025-05-22
08056446901090NExT Station AdvancedB98000960002025-05-19
08056446900642Galileo NT Line SoftwareB86400530002020-05-25
08056446900659Isolation Transformer ‘GP’ 110-120 VAC 50/60 HzB97000410012019-05-24
08056446900178Flash Led StimulatorB97000630002019-04-10
08056446900185USB FLASH ADAPTER CABLE L=3mB91006308002024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mB91006308102024-12-04
08056446900673Neurotravel LIGHTB98001020002024-12-04
08056446900680Neurotravel LIGHT Base UnitB97001020002024-12-04
08056446900895BE PLUS PRO LIGHTB97000780012024-12-04
08056446900901BE PLUS PRO STANDARDB97000780022024-12-04

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Primary DI, Brand, Company table
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04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
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04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22