Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

SEN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5050

Classification

FDA Product Code: SEN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5050
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown