Freespira Breathing System

Freespira is a biofeedback device that guides users through monitored breathing exercises to reduce stress. It measures exhaled carbon dioxide (EtCO2) levels and respiration rate via a sensor connected to a mobile app. For adults, it is indicated as adjunctive treatment for panic disorder and posttraumatic stress disorder; for adolescents aged 13-17, it treats stress and anxiety symptoms. The device requires healthcare provider direction and is used alongside other pharmacological or non-pharmacological interventions.

The subject device has identical design, dimensions, and materials as the predicate device (K180173). It maintains the same technological characteristics, including the sensor and mobile app for real-time biofeedback on EtCO2 and respiration rate. The fundamental difference is expanded labeling to include use in adolescents aged 13-17 for stress and anxiety disorders, whereas the predicate was limited to adults with panic disorder and PTSD.

Biocompatibility testing per ISO 10993-1:2009(R)2013; electromagnetic compatibility and electrical safety per IEC 60601-1:1988+A1:1991+A2:1995, ANSI/AAMI ES60601-1:2005, IEC/EN 60601-1-2:2007, IEC 60601-1-4:1996+A1:1999, and IEC 60601-1-11:2010; software verification per FDA guidance on software in medical devices.

Freespira is substantially equivalent because it has identical design, materials, and technological characteristics to the predicate K180173. Clinical data from feasibility studies, a randomized controlled trial in adolescents, and real-world evidence from 106 adolescents treated during COVID-19 demonstrate safety and effectiveness comparable to adults in the same treatment period. The expanded indication to adolescents aged 13-17 raised no new safety concerns—adverse events were similar to adult studies and the single rare event (facial numbness) resolved immediately upon stopping the exercise. Protocol adherence and symptom reduction rates in adolescents were equivalent to older age groups, supporting that the device performs as safely and effectively in this new population as in the predicate population.