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

    Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

    K Number: K171978 · Decision Oct 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    25
    Review Days
    94

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    Basic Information

    Device Name
    Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
    K Number
    K171978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    June 30, 2017
    Decision Date
    October 2, 2017
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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