FDA product code SEN: 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. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SEN, 1 in the last five years. The average 510(k) review took 573 days (median 573); 573 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety |
| Device class | Class II |
| Regulation | 21 CFR 882.5050 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for SEN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 573 |
Compare with all 510(k) review times · Search every SEN clearance
Top SEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Freespira, Inc. | 1 | 2025-04-24 |
Most recent SEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233337 | Freespira, Inc. | Freespira Breathing System | 2025-04-24 | 573 |
Recalls for SEN devices
openFDA lists no recalls for product code SEN.
Frequently asked questions
What is FDA product code SEN?
SEN is the FDA product code for biofeedback for adjunctive treatment of symptoms associated with stress and anxiety. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel.
What device class is SEN?
Class II, regulation 21 CFR 882.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEN?
Across 1 cleared submissions the average was 573 days from receipt to decision (median 573).
Which companies have the most SEN clearances?
Freespira, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SEN
- Run a recall and safety report across every SEN manufacturer
- Watch product code SEN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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