510(k) K233337
K233337 is an FDA 510(k) premarket notification submitted by Freespira, Inc. for the device "Freespira Breathing System". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code SEN (Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety), a Class II device regulated under 21 CFR 882.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2025
- Date Received
- September 29, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type
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.