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510(k) Data Aggregation

    K Number
    K090801
    Device Name
    ELECTRONIC HOUSE CALL
    Manufacturer
    EXPRESS MD SOLUTIONS, LLC
    Date Cleared
    2009-04-08

    (15 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXPRESS MD SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electronic House Call System (Electronic House Call Device + Electronic House Call Application + Electronic House Call Website) is a remote, retrospective monitoring tool for supplement in a patients' care. The Electronic House Call Device together with the Electronic House Call Application is intended to be a simple "store and forward" communications platform that allows clinicians and privileged users to access a patients' information for review through the Electronic House Call Website. The Electronic House Call Device is a tool to monitor patients' remotely and motivate them through education and reminders. The Electronic House Call System allows patients to measure vital signs without assistance from their healthcare provider. The Electronic House Call System is not intended to replace existing treatments or consultations, nor is it to be used as a substitute for a qualified healthcare professional's judgment/treatment plan. The Electronic House Call System is also not intended to act as an emergency response system.
    Device Description
    The Express MD Electronic House Call™ System is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and the patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website. If a patient is found to be outside of a pre-set parameter, the healthcare practitioner will respond according to their set policies. In addition, an email will be sent to the clinician. This email indicates that the nurse/clinician should review the website. This is not a real time alert or an alarm but an email that does not identify a patient, parameter or clinical state.
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