Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
The Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions is a prescription device that delivers stimulation using a general purpose computing platform to reduce sleep disturbance in patients experiencing this symptom due to psychiatric conditions such as nightmare disorder or post-traumatic stress disorder (PTSD). This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 882.5705 in the Neurology specialty. It carries product code QMZ and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QMZ
- Device Class
- FDA class 2
- Regulation Number
- 882.5705
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200033 | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable | Nov 06, 2020 | Unknown | Nightware, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.