510(k) K233337

Freespira Breathing System by Freespira, Inc. — Product Code SEN

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.