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510(k) Data Aggregation

    K Number
    K040086
    Device Name
    HEALTH BUDDY WITH BUDDYLINK
    Manufacturer
    HEALTH HERO NETWORK, INC.
    Date Cleared
    2004-03-10

    (54 days)

    Product Code
    DXN, CGA
    Regulation Number
    870.1130
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    Matched: '862.1245'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Health Buddy® with Buddylink is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
    Device Description
    The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment. The Health Buddy with Buddylink is a simple; user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send responses from the previous day and to retrieve the current day's dialogue. The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.
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