Device |
computerized behavioral therapy device for the treatment of fibromyalgia symptoms |
Definition |
Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms |
Physical State |
Mobile medical application (MMA) intended to be accessed via a patient’s smartphone |
Technical Method |
Computerized Behavioral Therapy |
Target Area |
N/A |
Regulation Medical Specialty |
Neurology |
Review Panel |
Physical Medicine |
Product Code | QWI |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
Submission Type |
510(k)
|
Regulation Number |
882.5804
|
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 |