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

    Air Compression Therapy Device, model: ST-502

    K Number: K213745 · Decision Mar 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    138
    Applicant Total
    2
    Review Days
    122

    Basic Information

    Device Name
    Air Compression Therapy Device, model: ST-502
    K Number
    K213745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Future Electronic Co., Ltd
    Date Received
    November 29, 2021
    Decision Date
    March 31, 2022
    Product Code
    IRP
    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
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Shenzhen Future Electronic Co., Ltd

    K Number Device Name
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