# QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

- Device class: 2; regulation: 21 CFR 882.5800; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 217 days (middle half 162–230)
- Recalls: 0 (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)
- 1995: 1
- 2003: 1
- 2006: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2019: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K903014: Alpha-Stim CS (1992), cited by 4
- K062284: Ces Ultra (2007), cited by 3
- K883812: HP-1 (Healthpax) (1988), cited by 2
- K230826: Modius Sleep (2023), cited by 1
- K903654: Liss Cranial Stimulator Model SBL202-B (1990), cited by 1
- K895175: NF-1 Mindpeace (1989), cited by 1

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