MagVenture Accelerated TMS (aTMS) Therapy System— 510(k) K260189
Substantially EquivalentTonica Elektronik A/S
FDA 510(k) clearance K260189 for MagVenture Accelerated TMS (aTMS) Therapy System, Substantially Equivalent on 2026-05-22. Applicant: Tonica Elektronik A/S. Device class: 2.
Summary
The MagVenture Accelerated TMS (aTMS) Therapy System comes from Tonica Elektronik A/S and is filed under OBP, transcranial magnetic stimulators.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Tonica Elektronik filed from Farum, Denmark. Review took 120 calendar days (January 22 to May 22, 2026).
Clearance details
- Applicant
- Tonica Elektronik A/S
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farum, DK
Recent devices under product code OBP
view allMore clearances from Tonica Elektronik A/S
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.