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, a class II device type, regulated under 21 CFR 882.5705. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QMZ
- Device name
- Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
- FDA 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).
- Regulation
- 21 CFR 882.5705
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QMZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
Applicants with the most clearances
Product code QMZ| Applicant | Clearances |
|---|---|
| Nightware | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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