# Tonica Elektronik A/S

- Location (FDA's records): Farum, DK
- FDA decisions: 18 (2006–2026): 18 510(k) clearances
- Product codes: OBP (10), GWF (5), QCI (1), HAW (1), QPL (1)
- 510(k) review time since 2016: median 119 days, against 125 for FDA's reviews in the same codes and years (7 of 11 faster)
- Predicates its devices cite: 45 (26 its own); citations of its devices by later devices: 54 (26 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neuronetics, Inc.: 5 (https://510kreport.com/company/neuronetics)
- The Magstim Company, Ltd.: 4 (https://510kreport.com/company/magstim)
- Dantec Medical, Inc.: 2 (https://510kreport.com/company/dantec-medical)
- Teleemg, LLC: 1 (https://510kreport.com/company/teleemg)
- Brainways, Ltd.: 1 (https://510kreport.com/company/brainways)
- Brainsway, Ltd.: 1 (https://510kreport.com/company/brainsway)
- Soterix Medical, Inc.: 1 (https://510kreport.com/company/soterix-medical)
- Neuralace Medical, Inc.: 1 (https://510kreport.com/company/neuralace-medical)

## Firms that cite its devices most
- BTL Industries, Inc.: 5 (https://510kreport.com/company/btl-industries)
- Teleemg, LLC: 4 (https://510kreport.com/company/teleemg)
- Brain Ultimate, Inc.: 4 (https://510kreport.com/company/brain-ultimate)
- The Magstim Company, Ltd.: 3 (https://510kreport.com/company/magstim)
- Neuroqore, Inc.: 2 (https://510kreport.com/company/neuroqore)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)
- Axilum Robotics: 1 (https://510kreport.com/company/axilum-robotics)
- Soterix Medical, Inc.: 1 (https://510kreport.com/company/soterix-medical)

## Its most-cited devices
- K150641: MagVita TMS Therapy System (2015), cited by 11
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (2018), cited by 9
- K171481: MagVita TMS Therapy System (2017), cited by 7
- K061645: Magpro, Model R30 (2006), cited by 5
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (2020), cited by 4
- K172667: MagVita TMS Therapy w/MagPro R20 (2017), cited by 3

## Recent decisions
- K260189: MagVenture Accelerated TMS (aTMS) Therapy System (May 22, 2026)
- K251125: MagVenture TMS Therapy System (Aug 11, 2025)
- K251119: MagVenture TMS Therapy System (Aug 8, 2025)
- K252032: T65  (9016E061-) (Jul 30, 2025)
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (Aug 25, 2023)
- K221544: MagVenture TMS Atlas Neuro Navigation System (Mar 17, 2023)
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (Aug 9, 2020)
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation (Aug 14, 2018)

Source page: https://510kreport.com/company/tonica-elektronik-a-s