FDA.reportPublic FDA data

Battery Charger

Primary DI
08056446900154
Brand
Battery Charger
Company
EB NEURO SPA
Model
B9100780100
Device description
Battery Charger for Battery Pack
Published
2019-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121996000
K242305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121996000BE PLUS LTM AMPLIFIER GWI AMPLIFIEREb Neuro S.P.A.2012-08-03GWL
K242305000BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.2024-09-04GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056446900154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446900154080564469001548056446900154

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

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
08056446901137NExT-HSB97001080002025-05-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009903715Quick-20mCGX, LLCGWL2025-09-29
B195EE223eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
B195EE225eego amplifiereemagine Medical Imaging Solutions GmbHGWL2025-09-29
00817111021332PolysmithNeurotronics, LLCGWL2025-09-23
08056446900338NeMus 2 600EB NEURO SPAGWL2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWL2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWL2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWL2025-05-22
08056446901113NExT-PADEB NEURO SPAGWL2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWL2025-05-22
08056446901137NExT-HSEB NEURO SPAGWL2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWL2025-05-22
08056446901199NExT-ASEB NEURO SPAGWL2025-05-22
08056446901205NExT StationEB NEURO SPAGWL2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWL2025-05-19
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
00814901021558Blackrock NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2025-02-14
08056446900673Neurotravel LIGHTEB NEURO SPAGWL2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWL2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWL2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWL2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWL2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWL2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWL2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWL2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWL2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWL2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWL2024-12-04
EBCI5730PRO0g.Nautilus PROg.tec medical engineering GmbHGWL2024-05-28
00814901021527Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWL2023-12-04