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510(k) Data Aggregation

    K Number
    K140772
    Device Name
    AEROSURE MEDIC
    Manufacturer
    Actegy Ltd
    Date Cleared
    2014-12-19

    (267 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Actegy Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device. - · The use of Aerosure improves clearance of secretions - · The use of Aerosure may reduce the need for postural drainage - Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems - · Aerosure may be used to prevent or reverse atelectasis · Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy. Aerosure may be used in hospital as well as the home after a period of training.
    Device Description
    Aerosure is a small, battery powered device. It produces a rapidly alternating occlusion of airflow as a user breathes through the replaceable valve head (containing the powered rotating vane mechanism) which creates a general increase in resistance to breathing and a vibration of the respiratory tree and the associated structures, including the musculature. Frequency is adjusted by switching modes.
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    K Number
    K123354
    Device Name
    REVITIVE IX
    Manufacturer
    Actegy Ltd
    Date Cleared
    2013-06-28

    (240 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Actegy Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revitive IX is indicated for: - Relaxation of muscle spasms; . - Prevention or retardation of disuse atrophy; ● - Increasing local blood circulation; . - Muscle re-education; . - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and . - Maintaining or increasing range of motion. .
    Device Description
    The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.
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