FDA.reportPublic FDA data

MagPro

Primary DI
05713484020215
Brand
MagPro
Company
Tonica Elektronik A/S
Model
MMC-140-II
Catalog number
9016E0631
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWFStimulator, Electrical, Evoked Response
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061645000
K160280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061645000MAGPRO, MODEL R30Tonica Elektronik A/S2006-10-31GWF
K160280000MagPro R20Tonica Elektronik A/S2016-05-16GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713484020215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713484020215057134840202155713484020215

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation system, mobileA mobile (on wheels) assembly of mains electricity (AC-powered) devices intended for the treatment and/or diagnosis 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8886247764infousa@magventure.com

Regulatory Flags#

DUNS number
566622973
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713484030245MagPro AccessoriesTable bracket for Super Flexible Arm9016B03912026-10-23
05713484031754MagPro AccessoriesSuper Flex Arm (short) Mini for MagPro R209016B09812026-10-23
05713484020154MagProMC-1259016E05552016-09-24
05713484020161MagProMC-B709016E05642016-09-24
05713484020482MagProCool Coil T659016E06112025-12-11
05713484031181MagPro accessoriesMarking Plate beam F39016B07612025-12-11
05713484031440MagPro accessoriesCoil Hub9016B09012025-12-11
05713484031648MagPro accessoriesMarking plate T65, left9016B09312025-12-11
05713484030214MagPro accessoriesHolder for MCF- and Cool Coils9016B03512025-03-13
05713484020468MagProCoil Cool B-70 CO9016E01812025-03-12
05713484030023MagPro accessoriesVacuum Pump Unit9016B01212025-03-12
05713484031426MagPro AccessoriesAccessories for X/R Trolley9016B05812025-03-12
05713484020109MagPro Cool B-65 A/P9016E05012022-12-08
05713484020192MagPro MC-P-B709016E05922022-11-28
05713484020208MagPro MCF-P-B659016E06012022-11-28
05713484031051MagPro AccessoriesMark. acc, MCF/Cool- B70, right 5.5cm9016B06322023-02-10
05713484031105MagPro AccessoriesSmall Neck Rest for Treatment Chair9016B04912023-02-10
05713484030290MagPro AccessoriesAcc for MagPro R209016B04412022-11-25
05713484031006MagPro Accessories360 Mounting kit for Monitor9016B07012025-02-04
05713484031013MagPro Accessories360 Gateway Unit9016C09012025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713484030245MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
05713484031754MagPro AccessoriesTonica Elektronik A/SOBP2026-10-23
10850005944963Hygiene Barrier, 50 PackNEURONETICS, INC.OBP2026-10-21
10850005944970Strap, Head PositioningNEURONETICS, INC.OBP2026-10-21
G792699APM21MUS00EXOMIND applicatorBTL INDUSTRIES FZEOBP2026-10-09
G792699HEADREST1MUS00HeadrestBTL INDUSTRIES FZEOBP2026-10-09
G792699PO2M21MUS00EXOMINDBTL INDUSTRIES FZEOBP2026-10-09
04250307604388N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604425N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307604449N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613526N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613533N/Ainomed Medizintechnik GmbHGWF2026-10-01
04250307613540N/Ainomed Medizintechnik GmbHGWF2026-10-01
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDOBP2026-08-25
00763000843908NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
00763000843915NIM VitalMEDTRONIC XOMED, INC.GWF2026-08-22
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
00199874344553MEGA-TMSSoterix Medical TechnologiesGWF2026-07-10
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