# K230826: Modius Sleep

- Pathway: 510(k) (Traditional)
- Applicant: Neurovalens, Ltd.
- Decided: Oct 27, 2023 after 217 days
- Product code: QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety)
- Device class: 2
- Regulation: 21 CFR 882.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883812 (1988). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062284: Ces Ultra, Neuro-Fitness, LLC (2007) Summary page 6.
- K903014: Alpha-Stim CS, Electromedical Products, Inc. (1992) Summary page 6.

## Most influential descendants
- K252951: Genesis Sleep (2025), 0 descendants of its own

## Indications for use
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults aged 22 and older.

Source page: https://510kreport.com/device/K230826
Methodology: https://510kreport.com/methodology