FDA product code SEN

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

Neurology·Class 2·21 CFR 882.5050
US regulatory classifications
US Product Code (FDA)
SEN
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5050
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.