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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    PowerDot PD-01MT2 Muscle Stimulator

    K Number: K210938 · Decision Jul 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    5
    Review Days
    123

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    Basic Information

    Device Name
    PowerDot PD-01MT2 Muscle Stimulator
    K Number
    K210938
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smartmissimo Technologies Pte, Ltd.
    Date Received
    March 29, 2021
    Decision Date
    July 30, 2021
    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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    Other Clearances by Smartmissimo Technologies Pte, Ltd.

    K Number Device Name
    K210269 PowerDot PD-01MT2 Muscle Stimulator
    K181759 PowerDot PD-01MT
    K172876 PowerDot PD-01M
    K150078 PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)