FDA product code QMZ

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Neurology·Class 2·21 CFR 882.5705
US regulatory classifications
US Product Code (FDA)
QMZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5705
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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).

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About this record

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.