QMZ

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Product code

QMZ

Device name

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Device class

Class 2

21 CFR

21 CFR 882.5705

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).