BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    X2ABS DUAL CHANNEL FITNESS BELT

    K Number: K102295 · Decision Feb 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    189

    Basic Information

    Device Name
    X2ABS DUAL CHANNEL FITNESS BELT
    K Number
    K102295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LETO ENTERPRISES INCORPORATION
    Date Received
    August 13, 2010
    Decision Date
    February 18, 2011
    Product Code
    NGX
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by LETO ENTERPRISES INCORPORATION

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