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510(k) Data Aggregation

    K Number
    K141273
    Device Name
    WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
    Manufacturer
    WELLDOC, INC
    Date Cleared
    2014-07-08

    (53 days)

    Product Code
    MRZ,LNX,NDC
    Regulation Number
    880.5725
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K100066,K112370,K120314
    Why did this record match?
    Reference Devices :

    K100066, K112370, K120314

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

    The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional. including prescriptions, diagnosis, or treatment.

    DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager@-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The DiabetesManager®)-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

    The DiabetesManager®-Rx System is not intended to replace the care provided by a Licensed healthcare professional, including prescriptions, diagnosis, or treatment.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents do not contain information about the acceptance criteria, study details, or device performance regarding the WellDoc BlueStar (WellDoc DiabetesManager® System and DiabetesManager®- Rx System).

    The documents are official FDA correspondence related to the 510(k) clearance (K141273) of the device. They confirm the substantial equivalence determination, state the regulatory classification and product codes, and outline the indications for use. However, they do not include the underlying clinical or performance study data that would detail acceptance criteria or device performance metrics.

    Therefore, I cannot provide the requested information based on the given input.

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