510(k) · Cleared
Recalled · 2007Ces Ultra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuro-Fitness, LLC · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cleared on Apr 5, 2007 as substantially equivalent to K895175 (Neurofitness, 1989) and 1 other predicate after a 241-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 5, 2007
- Review
- 241 days
- Class
- Class II
- Product code
- QJQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883812 (1988). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK883812 HP-1 (Healthpax)Healthdirections, Inc. · 1988 · Recalled
- This deviceK062284 Ces UltraNeuro-Fitness, LLC · 2007
- Descendant · cites it directly · 1 of its ownK230826 Modius SleepNeurovalens, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252951 Genesis SleepNeurofield, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232253 Modius StressNeurovalens Limited · 2024
- Descendant · cites it directly · 0 of its ownK182311 CervellaInnovative Neurological Devices, LLC · 2019
Most influential descendants
Showing 4 of 4 · See all- K230826Modius SleepNeurovalens, Ltd. · 2023 · cites it directly1descendant
- K252951Genesis SleepNeurofield, Inc. · 2025 · 2 generations on0descendants
- K232253Modius StressNeurovalens Limited · 2024 · cites it directly0descendants
- K182311CervellaInnovative Neurological Devices, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883812 | HP-1 (Healthpax) | Healthdirections, Inc. | 1988 | 1 |
| 0 (this device) | K062284 | Ces Ultra | Neuro-Fitness, LLC | 2007 | — |
| +1 | K230826 | Modius Sleep | Neurovalens, Ltd. | 2023 | — |
| +2 | K252951 | Genesis Sleep | Neurofield, Inc. | 2025 | — |
| +1 | K232253 | Modius Stress | Neurovalens Limited | 2024 | — |
| +1 | K182311 | Cervella | Innovative Neurological Devices, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJQ device
- #1 K252951 Genesis Sleepscore 11.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895175 | NF-1 MindpeaceSummary page 1…n Name: Stimulator, Cranial, Electrotherapy, a preamendment Class III device per 21 CFR § 882.5800 (JXK) Predicate Devices NF-1 Mindpeace CES, K895175, Neuro-Fitness, LLC HP-1 Healthpax CES, K883812, Healthdirections, Inc. Device Description The CES Ultra… | 1989 |
| * | K883812 | HP-1 (Healthpax)Summary page 1…reamendment Class III device per 21 CFR § 882.5800 (JXK) Predicate Devices NF-1 Mindpeace CES, K895175, Neuro-Fitness, LLC HP-1 Healthpax CES, K883812, Healthdirections, Inc. Device Description The CES Ultra is a device designed to deliver therapeutic electrical and Summary of… | 1988 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2007 | Not classified | Z-0712-2008 | Finished device change control | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K230826 (Neurovalens, Ltd., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QJQ devicesQJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · QJQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJQ
Too few QJQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QJQ
No recall names QJQ since 2007.
Adverse event reports per year · QJQ
39in 2023
MAUDE reports naming product code QJQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CES UltraTM is indicated for the treatment of insomnia, depression, or anxiety.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062284: Ces Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062284
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026