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

    Muscle Trainer

    K Number: K181728 · Decision Oct 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    10
    Review Days
    110

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    Basic Information

    Device Name
    Muscle Trainer
    K Number
    K181728
    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 Kentro Medical Electronics Co., Ltd.
    Date Received
    June 29, 2018
    Decision Date
    October 17, 2018
    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 Shenzhen Kentro Medical Electronics Co., Ltd.

    K Number Device Name
    K242332 Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
    K232517 Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
    K222870 Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
    K220998 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
    K200177 Low-frequency Multi-function physiotherapy instrument
    K200237 Transcutaneous Electronic Nerve Stimulator
    K191982 Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
    K183288 Transcutaneous Electrical Nerve Stimulator
    K170205 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203