| Device |
digital therapy device to reduce sleep disturbance for psychiatric conditions |
| Regulation Description |
Digital therapy device to reduce sleep disturbance for psychiatric conditions. |
| 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). |
| Physical State |
General purpose computing platform (consumer phone and watch) with associated sensors, software, and hardware to provide stimulus |
| Technical Method |
Uses software analysis of heart rate and motion measured during sleep on a general purpose computing platform to apply a stimulus to interrupt a sensed bout of disrupted sleep due to nightmare. |
| Target Area |
Wrist, upper/lower extremities, various locations on the body to sense physiological parameters and apply stimulus |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | QMZ |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5705
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
