# K062284: Ces Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Neuro-Fitness, LLC
- Decided: Apr 5, 2007 after 241 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883812 (1988). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895175: NF-1 Mindpeace, Neurofitness (1989) Summary page 1.
- K883812: HP-1 (Healthpax), Healthdirections, Inc. (1988) Summary page 1.

## Most influential descendants
- K230826: Modius Sleep (2023), 1 descendant of its own
- K252951: Genesis Sleep (2025), 0 descendants of its own
- K232253: Modius Stress (2024), 0 descendants of its own
- K182311: Cervella (2019), 0 descendants of its own

## Recalls of this device
- Oct 29, 2007 · Not classified · Z-0712-2008: No FDA clearance for the .35Hz/.45Hz frequency option on device.

## Indications for use
The CES UltraTM is indicated for the treatment of insomnia, depression, or anxiety.

Source page: https://510kreport.com/device/K062284
Methodology: https://510kreport.com/methodology