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

    Veinoflow SCD (Model: LBTK-M-I 5006)

    K Number: K213313 · Decision Feb 9, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    3
    Review Days
    128

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    Basic Information

    Device Name
    Veinoflow SCD (Model: LBTK-M-I 5006)
    K Number
    K213313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dalian Labtek Science & Development Co., Ltd.
    Date Received
    October 4, 2021
    Decision Date
    February 9, 2022
    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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    Other Clearances by Dalian Labtek Science & Development Co., Ltd.

    K Number Device Name
    K123830 INTERMITTENT PNEUMATIC COMPRESSION DEVICE
    K121718 A-V FOOT PUMP