FDA product code QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QJQ is the FDA product code for cranial electrotherapy stimulator to treat insomnia and/or anxiety. It is a Class II device, regulated under 21 CFR 882.5800 and reviewed by the Neurology panel. FDA has cleared 19 510(k) submissions under QJQ, 3 in the last five years, from 18 different applicants. The average 510(k) review took 249 days (median 202); 174 days on average over the last three years. FDA has posted 1 recall for QJQ devices, 1 initiated in the last five years.
Definition
To provide electrical current to the head to treat insomnia and/or anxiety
Classification
| Field | Value |
|---|---|
| Device name | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
| Device class | Class II |
| Regulation | 21 CFR 882.5800 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QJQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 195 |
| 2023 | 1 | 217 |
| 2024 | 1 | 243 |
| 2025 | 1 | 106 |
Compare with all 510(k) review times · Search every QJQ clearance
Top QJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Consultants Intl. , Ltd. | 2 | 1990-10-04 |
| Neurofield, Inc. | 1 | 2025-12-31 |
| Neurovalens Limited | 1 | 2024-03-27 |
| Neurovalens , Ltd. | 1 | 2023-10-27 |
| Innovative Neurological Devices, LLC | 1 | 2019-03-07 |
13 more applicants have QJQ clearances. See the full list in Caduvo.
Most recent QJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252951 | Neurofield, Inc. | Genesis Sleep | 2025-12-31 | 106 |
| K232253 | Neurovalens Limited | Modius Stress | 2024-03-27 | 243 |
| K230826 | Neurovalens , Ltd. | Modius Sleep | 2023-10-27 | 217 |
| K182311 | Innovative Neurological Devices, LLC | Cervella | 2019-03-07 | 195 |
| K090052 | Johari Digital Healthcare , Ltd. | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | 2009-05-29 | 142 |
Recalls for QJQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-04-06.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code QJQ?
QJQ is the FDA product code for cranial electrotherapy stimulator to treat insomnia and/or anxiety. It is a Class II device, regulated under 21 CFR 882.5800 and reviewed by the Neurology panel.
What device class is QJQ?
Class II, regulation 21 CFR 882.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJQ?
Across 19 cleared submissions the average was 249 days from receipt to decision (median 202).
Which companies have the most QJQ clearances?
Medical Consultants Intl. , Ltd. (2); Neurofield, Inc. (1); Neurovalens Limited (1); Neurovalens , Ltd. (1); Innovative Neurological Devices, LLC (1).
Have QJQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code QJQ
- Run a recall and safety report across every QJQ manufacturer
- Watch product code QJQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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