# K252032: T65  (9016E061-)

- Pathway: 510(k) (Special)
- Applicant: Tonica Elektronik A/S
- Decided: Jul 30, 2025 after 30 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070003 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150641: MagVita TMS Therapy System, Tonica Elektronik A/S (2015) Summary page 6.

## Indications for use
Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K252032
Methodology: https://510kreport.com/methodology