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

    3 in 1 TENS UNIT (TC1241, TC2241, TS1241)

    K Number: K251187 · Decision Jul 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    8
    Review Days
    102

    Basic Information

    Device Name
    3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
    K Number
    K251187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Changsha Anxiang Medical Technology Co., Ltd.
    Date Received
    April 17, 2025
    Decision Date
    July 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.

    TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS/EMS device (GUSE01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VEINOPLUS Back

    FDA 510(k)
    FDA Class 2 ·Neurology

    Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

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

    K Number Device Name
    K251429 OTC 4-Channel Rechargeable TENS Unit
    K251706 TENS and EMS Unit
    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)