Data / Medical devices / Denmark / Magventure A/S
Magventure A/S: FDA-registered device maker in Farum Hovedstaden, Denmark, 18 510(k) clearances
Magventure A/S is registered with the FDA (registration 3012352782) in Farum Hovedstaden, Denmark. It lists 6 device types. The FDA files 18 510(k) clearances under its listings, the newest dated August 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012352782
- Address
- Lucernemarken 15, Farum Hovedstaden, Denmark, 3520
- Owner or operator
- MagVenture A/S (10049990)
- Roles
- Exporter to the US
- First device listed
- October 5, 2015
- Registered through
- 2026
- Brand names listed
- Coil T65, Express TMS Therapy, MEP Monitor, MagPro, MagPro R20, MagPro magnetic coils, MagVenture Pain Therapy, MagVenture TMS Atlas Neuro Navigation System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromagnetic Stimulator, Pain Relief | QPL | 2 | Exporter to the US | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US | accessdata.fda.gov |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | 2 | Exporter to the US | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2025 | K251125 | MagVenture TMS Therapy System | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| August 8, 2025 | K251119 | MagVenture TMS Therapy System | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| July 30, 2025 | K252032 | T65 (9016E061-) | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| August 25, 2023 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | QPL | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| March 17, 2023 | K221544 | MagVenture TMS Atlas Neuro Navigation System | HAW | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| August 9, 2020 | K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system | QCI | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| August 14, 2018 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| October 5, 2017 | K172667 | MagVita TMS Therapy w/MagPro R20 | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| July 25, 2017 | K171967 | MagVita TMS Therapy System | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| June 16, 2017 | K171481 | MagVita TMS Therapy System | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| May 1, 2017 | K170114 | MagVita TMS Therapy - w/MagPro R20 | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| March 31, 2017 | K162873 | MEP Monitor | GWF | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| May 16, 2016 | K160280 | MagPro R20 | GWF | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| July 31, 2015 | K150641 | MagVita TMS Therapy System | OBP | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| March 26, 2010 | K091940 | MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION | GWF | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| July 27, 2007 | K071821 | COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 | GWF | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| October 31, 2006 | K061645 | MAGPRO, MODEL R30 | GWF | Substantially Equivalent | Tonica Elektronik A/S | accessdata.fda.gov |
| August 31, 1993 | K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | GWF | Substantially Equivalent | Dantec Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transcranial Magnetic Stimulator
- All makers of Electromagnetic Stimulator, Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Neurological Stereotaxic Instrument
- All makers of Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Updated August 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.