DeviceClearance

Product code SEN— Neurology

Freespira Breathing System

Classification name
Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
Device class
Class 2
Regulation
21 CFR 882.5050
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SEN under 21 CFR 882.5050, via openFDA

Market context for product code SEN

FDA has cleared 1 device under product code SEN, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEN

Recent clearances under product code SEN

Data sourced from openFDA. This site is unofficial and independent of the FDA.