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510(k) Data Aggregation

    K Number
    K180173
    Device Name
    Freespira
    Manufacturer
    Palo Alto Health Sciences, Inc.
    Date Cleared
    2018-08-23

    (213 days)

    Product Code
    HCC, CCK
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Palo Alto Health Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Freespira is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.
    Device Description
    Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or nonpharmacological interventions. Freespira is authorized and overseen by a licensed healthcare provider. Patients are trained to use the Freespira Sensor and the Freespira Mobile App to measure and display their exhaled carbon dioxide (EtCO₂) level and respiration rate (RR) and how different breathing habits affect EtCO2 levels.
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    K Number
    K131586
    Device Name
    CANCARY BREATHING SYSTEM
    Manufacturer
    PALO ALTO HEALTH SCIENCES, INC.
    Date Cleared
    2013-12-10

    (193 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALO ALTO HEALTH SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Canary Breathing" System is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.
    Device Description
    The CBS is a biofeedback device that provides the user with a series of tone-guided breathing exercises and an awareness of his or her physiological data. The CBS uses standard biofeedback concepts to teach the patient to regulate their end-tidal CO2 (EtCO2) and respiratory rate (RR). The user's physiological data display allows the patient to see l ) the actual rate of their breathing and 2) how changes in breathing mechanics (depth and volume) affect EtCO2 levels. The CBS consists of a biofeedback training software program (mobile app) and an EtCO2 sensor (capnometer) used with a nasal cannula. The mobile app guides the user through an exercise and displays physiological data, while the sensor collects physiological data and feeds it to the mobile application for biofeedback. The patient's EtCO2 levels and RR are relaved from the capnometer to the mobile application via Bluetooth and are displayed on a tablet device, through the mobile application.
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