# K260402: MeRT System

- Pathway: 510(k) (Traditional)
- Applicant: Wave Neuroscience
- Decided: Jun 3, 2026 after 117 days
- Product code: SIG (Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd))
- Device class: 2
- Regulation: 21 CFR 882.5802
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to DEN070003 (2008). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251119: MagVenture TMS Therapy System, Tonica Elektronik A/S (2025) Summary page 5.

## Indications for use
The MeRT System is intended to be used as an adjunct for the treatment of adult patients suffering from Post Traumatic Stress Disorder (PTSD).

Source page: https://510kreport.com/device/K260402
Methodology: https://510kreport.com/methodology