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

    Fitness Belt (Model: KLT-07)

    K Number: K231136 · Decision Jun 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    56

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    Basic Information

    Device Name
    Fitness Belt (Model: KLT-07)
    K Number
    K231136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Kelutongda Industrial Co., Ltd.
    Date Received
    April 21, 2023
    Decision Date
    June 16, 2023
    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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