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U.S. Department of Health and Human Services

Product Classification

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Device 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 CodeQMZ
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
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
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