FDA.reportPublic FDA data

MagPro Accessories

Primary DI
05713484030245
Brand
MagPro Accessories
Company
Tonica Elektronik A/S
Model
Table bracket for Super Flexible Arm
Catalog number
9016B0391
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170114000
K171967000
K172667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170114000MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S2017-05-01OBP
K171967000MagVita TMS Therapy SystemTonica Elektronik A/S2017-07-25OBP
K172667000MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S2017-10-05OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713484030245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713484030245057134840302455713484030245

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.

Regulatory Flags#

DUNS number
566622973
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05713484031020MagPro Accessories360 Monitor9016C09112025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B108699APM1MUS00EXOMIND Dual applicatorBTL INDUSTRIES LIMITEDOBP2026-08-25
06971538581788NeuronavigatorShenzhen Yingzhi Technology Co.,Ltd.OBP2026-08-21
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
04650075333273CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
04650075337783CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
00850005944935NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-15
05713484020482MagProTonica Elektronik A/SOBP2025-12-11
05713484031181MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031440MagPro accessoriesTonica Elektronik A/SOBP2025-12-11