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

    Venen-trainer (Model: FM150, SFM90)

    K Number: K203746 · Decision Nov 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    9
    Review Days
    323

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    Basic Information

    Device Name
    Venen-trainer (Model: FM150, SFM90)
    K Number
    K203746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Pango Electronic Co., Ltd.
    Date Received
    December 22, 2020
    Decision Date
    November 10, 2021
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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