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Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

FDA product code SEN · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5050
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-04-24 – 2025-04-24

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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