FDA.reportPublic FDA data

Butterfly Coil 70 mm air cooled

Primary DI
08056446900611
Brand
Butterfly Coil 70 mm air cooled
Company
EB NEURO SPA
Model
B9621086004
Device description
Magnetic stimulation coil
Published
2019-05-24
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
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150220000STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-FastEb Neuro S.P.A.2015-08-19GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056446900611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056446900611080564469006118056446900611

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation system, stationaryA stationary assembly of mains electricity (AC-powered) devices intended for the treatment of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools to enhance the therapeutic effect.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
339182263
Device count
1
Serial number
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
B006NVHS102NONENeurovision Medical Products, Inc.GWF2025-12-18
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
00190376530024SafeOp 3ALPHATEC SPINE, INC.GWF2024-11-12
B006NVPTKITC3P6WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P7WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTKITC3P8WSF52Nerveana+®Neurovision Medical Products, Inc.GWF2024-02-01
B006NVPTST2Nerveana+®Neurovision Medical Products, Inc.GWF2023-12-04
B006NVPTKITC3P652Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P6T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P752Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P7T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P852Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPTKITC3P8T52Nerveana+®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P6T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P7T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8D52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVTKITC3P8T52Nerveana®Neurovision Medical Products, Inc.GWF2023-04-20
B006NVPIC61Nerveäna+®Neurovision Medical Products, Inc.GWF2023-04-11