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510(k) Data Aggregation

    K Number
    K132173
    Device Name
    FAMILY HEALTHWARE
    Manufacturer
    SANITAS, INC.
    Date Cleared
    2014-05-30

    (319 days)

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

    SANITAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.
    Device Description
    Family Healthware™ is a Web-based software tool that can be used to assess a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following: - Health behaviors (e.g., smoking and exercise), - Screening tests (e.g., blood cholesterol and mammography), - Health history among his or her first- and second-degree relatives. One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk. health behaviors, and screening results to generate personalized prevention messages.
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    K Number
    K123671
    Device Name
    WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
    Manufacturer
    SANITAS, INC.
    Date Cleared
    2013-01-16

    (48 days)

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

    SANITAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wellaho™ Personalized Outpatient Management System is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
    Device Description
    Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
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