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

    TENS and EMS Unit

    K Number: K251706 · Decision Jul 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    8
    Review Days
    57

    Basic Information

    Device Name
    TENS and EMS Unit
    K Number
    K251706
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Changsha Anxiang Medical Technology Co., Ltd.
    Date Received
    June 3, 2025
    Decision Date
    July 30, 2025
    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 Changsha Anxiang Medical Technology Co., Ltd.

    K Number Device Name
    K251429 OTC 4-Channel Rechargeable TENS Unit
    K251187 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
    K250759 3 in 1 TENS UNIT
    K243763 Wireless TENS & EMS Unit
    K243511 OTC TENS & EMS Unit
    K242787 Tens & Ems Device (TU1080)
    K242567 Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)