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

    OTC 4-Channel Rechargeable TENS Unit

    K Number: K251429 · Decision Aug 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    8
    Review Days
    112

    Basic Information

    Device Name
    OTC 4-Channel Rechargeable TENS Unit
    K Number
    K251429
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Changsha Anxiang Medical Technology Co., Ltd.
    Date Received
    May 8, 2025
    Decision Date
    August 28, 2025
    Product Code
    NUH
    Advisory Committee
    Neurology
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Changsha Anxiang Medical Technology Co., Ltd.

    K Number Device Name
    K251706 TENS and EMS 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)
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