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510(k) Data Aggregation

    K Number
    K952979
    Device Name
    HANC NETWORK
    Manufacturer
    HEALTHTECH SERVICES CORP.
    Date Cleared
    1996-07-25

    (394 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHTECH SERVICES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANC™ Network is intended to be used as a clinical tool to provide a method of monitoring a patient's health status at home and a method for transferring the data to a nurse for review. The HANC™ Network is indicated for use for patients that require medical observation and monitoring while at home, who have medication or therapy compliance issues, and who need training reinforcement. The HANC™ Network is not a patient emergency response system. It does not analyze patient information and does not offer medical advice to the patient. It collects, stores, and transmits patient information to the health professional.
    Device Description
    The HANC™ Network is a patient-support system designed to enhance the quality and lower the cost of healthcare services. The system consists of two parts: (1) a programmable device called the Home Assisted Nursing Care ("HANC"M") unit that monitors and transmits health information from a remote site such as a patient's home; and (2) a Remote Nursing Interface that receives, stores, and prints data for nurse or physician review. The HANC™ unit is a speech and/or touch screen-activated device designed to monitor and assist patients in their homes. It coaches the patient in a conversational manner and manages patient schedules, takes vital signs, and has the ability to communicate over phone lines with an off-site Remote Nursing Interface that provides monitoring of the patient. The HANC™ unit may be used to perform measurements of pulse, blood pressure, temperature, blood oxygen saturation, and electrocardiogram (ECG). In addition, the HANC™ unit incorporates other features such as recording stethoscope sounds, capturing a video image, reminding patients to take medications, coaching screens, inputing data manually, and calling the nurse.
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