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510(k) Data Aggregation

    K Number
    K130856
    Device Name
    BIA / VITALITY ANALYZER
    Manufacturer
    IPGDX, LLC
    Date Cleared
    2013-11-25

    (242 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIA / VITALITY ANALYZER

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

    The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.

    Device Description

    Not Found

    AI/ML Overview

    While the provided text describes the FDA 510(k) clearance for the Vitality Analyzer™/BIA Analyzer™, it does not contain the specific acceptance criteria or details of a study (test data, sample sizes, expert qualifications, etc.) that proves the device meets those criteria.

    The document is a regulatory clearance letter, confirming the device's substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include the technical performance evaluation that would typically involve acceptance criteria and a study.

    Therefore, I cannot provide the requested information in the format requested. The document primarily focuses on regulatory approval rather than detailed performance evaluation.

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