Last synced on 27 January 2023 at 11:04 pm

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5705
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QMZ is linked to regulation 21CFR882.5705, which does not seem to exist yet. It may be pending at the moment.

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5705
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QMZ is linked to regulation 21CFR882.5705, which does not seem to exist yet. It may be pending at the moment.