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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5705

Medical specialty

Neurology

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).

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