| Device |
biofeedback for adjunctive treatment of symptoms associated with stress and anxiety |
| Regulation Description |
Biofeedback device. |
| Definition |
A biofeedback device for adjunctive treatment of patient-reported symptoms associated with stress and anxiety is intended to provide feedback to users with patient-reported symptoms associated with stress and anxiety on a physiological measurement as a relaxation treatment for the reduction of stress and anxiety. |
| Physical State |
The biofeedback device for adjunctive treatment of associated with stress and anxiety includes a sensor to measure a physiological parameter and a mechanism to provide information on that parameter to the user as part of exercises that aid in relaxation |
| Technical Method |
A biofeedback device for adjunctive treatment of associated with stress and anxiety provides feedback corresponding to the status of one or more of a patient's physiological parameters (e.g., breath, heart rate, brain alpha wave activity, muscle activity, skin temperature, etc.) to assist the user through exercises that aid in relaxation |
| Target Area |
Software |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SEN |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5050
|
|---|
| 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 |
