Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QMZ · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5705
Classification
FDA Product Code
QMZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5705
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).