SEN

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

Product code

SEN

Device name

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

Device class

Class 2

21 CFR

21 CFR 882.5050

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-24.