FLOJO UTILIZES A BREATHING SYSTEM (ABS)

ABS is intended to induce relaxation by leading the patient through interactively guided and monitored breathing exercises.
 

ABS is indicated for use only as an adjunctive treatment for the reduction of some mild to moderate symptoms of stress and anxiety.

 

For the best results, the ABS should be played daily for at least 15 minutes per session at least 45 minutes per week.

 

If you are experiencing symptoms of stress or anxiety, please contact your physician before using the ABS.

 

If you experience new or worsening symptoms while playing ABS, or have
thoughts of self-harm, discontinue play and consult a healthcare provider.

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A Breathing System (ABS) is intended as supplemental care and is not a replacement for traditional mental health treatment, such as psychotherapy and medication. While results will vary, a player should expect to feel results within the first week of play.

 

ABS has been released in compliance with the FDA Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and is in clinical testing. No other premarket evaluation has been
completed at this time. Additional risks and benefits may exist that have not been clinically evaluated.