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

    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

    K Number: K233070 · Decision Mar 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    4
    Review Days
    169

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    Basic Information

    Device Name
    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    K Number
    K233070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chongqing Rob Linka Science and Technology Co., Ltd.
    Date Received
    September 26, 2023
    Decision Date
    March 13, 2024
    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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    Other Clearances by Chongqing Rob Linka Science and Technology Co., Ltd.

    K Number Device Name
    K233067 Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    K233092 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
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