Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Medical specialty
Neurology
Device class
2
Regulation number
882.5705
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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).