Product code SEN

Device name

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

Medical specialty

Neurology

Device class

2

Regulation number

882.5050

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset