Device typeMindfulness/behavioural therapy software, non-clinician-consultative: A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician.
FDA categoryComputerized Behavioral Therapy Device For Treating Symptoms
Device ID00860006172008
Catalog number01-0001-001
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information