QMZClass II
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Neurology · 21 CFR 882.5705
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).
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code