510(k) Report

FDA applicant

Tonica Elektronik A/S

Farum, DK18 decisions2006–20260 recalls

FDA records 18 decisions for Tonica Elektronik A/S (Farum, DK) from 2006 to 2026: 18 510(k) clearances. Most are in product codes OBP (Transcranial Magnetic Stimulator) and GWF (Stimulator, Electrical, Evoked Response). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 26 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Tonica Elektronik A/S’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 12010: 12015: 12016: 12017: 52018: 12020: 12023: 22025: 32026 (partial year): 1
2007high 5 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tonica Elektronik A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tonica Elektronik A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OBPTranscranial Magnetic Stimulator10decisions
  • GWFStimulator, Electrical, Evoked Response5decisions
  • QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder1decision
  • HAWNeurological Stereotaxic Instrument1decision
  • QPLElectromagnetic Stimulator, Pain Relief1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 125 days; 7 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 45 predicates; 26 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 54 times; 26 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150641MagVita TMS Therapy SystemTonica Elektronik A/S · 201511cite it
  • K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 20189cite it
  • K171481MagVita TMS Therapy SystemTonica Elektronik A/S · 20177cite it
  • K061645Magpro, Model R30Tonica Elektronik A/S · 20065cite it
  • K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 20204cite it
  • K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S · 20173cite it

What has FDA decided for it lately?

  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026
  • K251125MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K251119MagVenture TMS Therapy SystemTonica Elektronik A/S · 2025
  • K252032T65 (9016E061-)Tonica Elektronik A/S · 2025
  • K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/S · 2023
  • K221544MagVenture TMS Atlas Neuro Navigation SystemTonica Elektronik A/S · 2023
  • K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020
  • K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018

All 18 as Tonica Elektronik A/S →