SEN — Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety Class II
FDA product code SEN covers "Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety", a Class II medical device regulated under 21 CFR 882.5050. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEN
- Device Class
- Class II
- Regulation Number
- 882.5050
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233337 | freespira | Freespira Breathing System | April 24, 2025 |