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Sign in to claim this brandTonica Elektronik A/S
US
Last updated May 24, 2026
What Tonica Elektronik A/S makes
Tonica Elektronik A/S manufactures magnetic neural stimulation systems, including the MagPro series and its associated accessories. These devices are designed for transcranial magnetic stimulation (TMS) applications, targeting neurological and psychiatric conditions through non-invasive brain stimulation.
The company’s products are classified as Class II devices under FDA regulations and are authorised via 510(k) and UDI pathways. The portfolio is listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tonica Elektronik A/S manufacture?
Tonica Elektronik A/S specialises in magnetic neural stimulation systems, specifically devices designed for transcranial magnetic stimulation (TMS). These systems are used in medical applications to stimulate the brain non-invasively, often for treating neurological or psychiatric conditions. The primary product line includes the MagPro series and its associated accessories.
Where is Tonica Elektronik A/S based?
Tonica Elektronik A/S is headquartered in the United States. The company’s location is relevant for regulatory compliance and device authorisation processes, particularly under FDA guidelines.
How are Tonica Elektronik A/S’s devices classified under FDA regulations?
Tonica Elektronik A/S’s magnetic neural stimulation systems are classified as Class II devices by the FDA. This classification is based on their intended use and risk level, requiring compliance with specific regulatory controls to ensure safety and effectiveness before authorisation.
Which regulatory databases or registries list Tonica Elektronik A/S’s devices?
Tonica Elektronik A/S’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries confirm the devices’ authorisation status and compliance with FDA requirements for magnetic neural stimulation systems.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- magventure.com
- —
- —
- [email protected]
- Phone
- 8886247764
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 566622973
Catalogue (94)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MagPro Accessories | TextileCaps, Bundle | FDA UDI | Class II | Active |
| MagPro Accessories | Flow Arm | FDA UDI | Class II | Active |
| MagPro | MC-125 | FDA UDI | Class II | Active |
| MagPro Accessories | Markning acc. MCF/B-70 Clips-on, Left 5.5 cm | FDA UDI | Class II | Active |
| MagPro Accessories | Trolley for MagPro X/R- High | FDA UDI | Class II | Active |
| MagPro | MCF-75 | FDA UDI | Class II | Active |
| MagPro | R20 | FDA UDI | Class II | Active |
| MagPro | Cool D-B80 | FDA UDI | Class II | Active |
| MagPro Accessories | Flow Arm Coil adapter kit, ø38-2pcs | FDA UDI | Class II | Active |
| MagPro Accessories | Wall mount Bracket for Flexible Arm | FDA UDI | Class II | Active |
| MagPro | C-B70 | FDA UDI | Class II | Active |
| MagPro | Cool-B70 | FDA UDI | Class II | Active |
| MagPro Accessories | Isolation Transformer 120 V | FDA UDI | Class II | Active |
| MagPro | Cool-B65 | FDA UDI | Class II | Active |
| MagPro | MMC-140 | FDA UDI | Class II | Active |
| MagPro Accessories | Universal Holder | FDA UDI | Class II | Active |
| MagPro | R30 | FDA UDI | Class II | Active |
| MagPro accessories | Holder for MCF- and Cool Coils | FDA UDI | Class II | Active |
| MagPro Accessories | Mark. acc. C-B70, 5.5cm left | FDA UDI | Class II | Active |
| MagPro | C-100 | FDA UDI | Class II | Active |
| MagPro Accessories | 360 Monitor | FDA UDI | Class II | Active |
| MagPro Accessories | Pillow Case 70 cm (pack of 5pcs) | FDA UDI | Class II | Active |
| MagPro Accessories | Trolley for MagPro R20 | FDA UDI | Class II | Active |
| MagPro Accessories | 360 Mounting kit for Monitor | FDA UDI | Class II | Active |
| MagPro Accessories | 360 Gateway Unit | FDA UDI | Class II | Active |
| MagPro Accessories | Small Neck Rest for Treatment Chair | FDA UDI | Class II | Unknown |
| MagPro Accessories | Acc. for G3 Trolley | FDA UDI | Class II | Active |
| Magpro, Model R30 | K061645 | FDA 510(k) | Class II | Active |
| MagVita TMS Therapy w/MagPro R20 | K172667 | FDA 510(k) | Class II | Active |
| MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | K193006 | FDA 510(k) | Class II | Active |
| MagPro R20 | K160280 | FDA 510(k) | Class II | Active |
| MagVita TMS Therapy System | K171967 | FDA 510(k) | Class II | Active |
| Magpro, Models R30 With Magoption, X100, X100 With Magoption | K091940 | FDA 510(k) | Class II | Active |
| MEP Monitor | K162873 | FDA 510(k) | Class II | Active |
| MagVenture TMS Therapy System | K251125 | FDA 510(k) | Class II | Active |
| MagVenture TMS Atlas Neuro Navigation System | K221544 | FDA 510(k) | Class II | Active |
| T65 (9016e061-) | K252032 | FDA 510(k) | Class II | Active |
| MagVita TMS Therapy System | K171481 | FDA 510(k) | Class II | Active |
| MagVita TMS Therapy - w/MagPro R20 | K170114 | FDA 510(k) | Class II | Active |
| MagVita TMS Therapy System | K150641 | FDA 510(k) | Class II | Active |
| MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption | K230014 | FDA 510(k) | Class II | Active |
| Mag Vita TMS Therapy System w/Theta Burst Stimulation | K173620 | FDA 510(k) | Class II | Active |
| MagVenture TMS Therapy System | K251119 | FDA 510(k) | Class II | Active |
| Coils, Models Mcf-B65, Mcf-75, Mcf-125 And Cool-B65 | K071821 | FDA 510(k) | Class II | Active |
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