SEN · Class II · 21 CFR 882.5050

FDA Product Code SEN: Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety

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.

Leading manufacturers include Freespira, Inc..

1
Total
1
Cleared
573d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety Devices (Product Code SEN)

1 devices
1–1 of 1
Cleared Apr 24, 2025
Freespira Breathing System
K233337
Freespira, Inc.
Neurology · 573d

About Product Code SEN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEN since 2025, with 1 receiving FDA clearance (average review time: 573 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEN devices are reviewed by the Neurology panel. Browse all Neurology devices →