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

    Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

    K Number: K231318 · Decision Jul 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
    K Number
    K231318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Adss Development Co., Ltd.
    Date Received
    May 8, 2023
    Decision Date
    July 7, 2023
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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