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510(k) Data Aggregation

    K Number
    K030203
    Device Name
    LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
    Date Cleared
    2003-04-21

    (90 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONG WELL ELECTRONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 10 to 80 years old. The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.
    Device Description
    LONG WELL LW-6Dxx Series Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
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