Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
SEN is the FDA product code for Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety, a class II device type, regulated under 21 CFR 882.5050. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SEN
- Device name
- Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
- FDA 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.
- Regulation
- 21 CFR 882.5050
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SEN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SEN| Applicant | Clearances |
|---|---|
| Freespira, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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