# K232253: Modius Stress

- Pathway: 510(k) (Traditional)
- Applicant: Neurovalens Limited
- Decided: Mar 27, 2024 after 243 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
Modius Stress is a non-invasive, home-use neurostimulation device that is indicated to treat the symptoms of Generalized Anxiety Disorder in adults aged 22 and older, when used for approximately 4 weeks. Durability of effect after 4 weeks has not been established.

Source page: https://510kreport.com/device/K232253
Methodology: https://510kreport.com/methodology