Device |
computerized behavioral therapy device for substance use disorders |
Regulation Description |
Computerized behavioral therapy device for psychiatric disorders. |
Definition |
The device is intended to provide cognitive behavioral therapy to treat substance use disorder. |
Physical State |
The device is a software-based mobile app downloaded onto a smartphone. |
Technical Method |
The device is a software-based mobile app that provides a computerized version of behavioral therapy to the patient. |
Target Area |
The device is intended to provided psychiatric treatment. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | PWE |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5801
|
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 |