# JXK: Cranial Electrotherapy Stimulator To Treat Depression

- Device class: 3; regulation: 21 CFR 882.5800; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2025: 2
- 2026: 1

## Most-cited predicates

Source page: https://510kreport.com/product-code/JXK
Data by year (CSV): https://510kreport.com/product-code/JXK.csv