FDA product code QMZ: Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QMZ is the FDA product code for digital therapy device to reduce sleep disturbance for psychiatric conditions. It is a Class II device, regulated under 21 CFR 882.5705 and reviewed by the Neurology panel. Devices under QMZ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post traumatic stress disorder (PTSD).
Classification
| Field | Value |
|---|---|
| Device name | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions |
| Device class | Class II |
| Regulation | 21 CFR 882.5705 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QMZ devices
openFDA lists no recalls for product code QMZ.
Frequently asked questions
What is FDA product code QMZ?
QMZ is the FDA product code for digital therapy device to reduce sleep disturbance for psychiatric conditions. It is a Class II device, regulated under 21 CFR 882.5705 and reviewed by the Neurology panel.
What device class is QMZ?
Class II, regulation 21 CFR 882.5705. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QMZ
- Run a recall and safety report across every QMZ manufacturer
- Watch product code QMZ 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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