QMZ — Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions Class II
FDA product code QMZ covers "Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions", a Class II medical device regulated under 21 CFR 882.5705. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QMZ
- Device Class
- Class II
- Regulation Number
- 882.5705
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200033 | nightware | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Wat | November 6, 2020 |