SEN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5050
- Medical specialty
- Neurology
- 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.
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| Record | Firm | Date |
|---|---|---|
| Freespira Breathing System (K233337) | Freespira, Inc. | 2025-04-24 |
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