FDA.reportPublic FDA data

MagPro

Primary DI
05713484020482
Brand
MagPro
Company
Tonica Elektronik A/S
Model
Cool Coil T65
Catalog number
9016E0611
Device description
Magnetic stimulation coil
Published
2025-12-11
Public version status
New
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
K252032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252032000T65 (9016E061-)Tonica Elektronik A/S2025-07-30OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713484020482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713484020482057134840204825713484020482

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-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
05713484020154MagProMC-1259016E05552016-09-24
05713484020161MagProMC-B709016E05642016-09-24
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
05713484031020MagPro Accessories360 Monitor9016C09112025-02-04
05713484030016MagPro AccessoriesTrolley for MagPro X/R9016B01022022-11-28
05713484030047MagPro AccessoriesCoil Cooler9016B01512022-11-28

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Primary DI, Brand, Company table
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08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
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