BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Hi-Dow Wireless TENS/EMS System (Model HD-5N)

    K Number: K163393 · Decision Aug 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    245

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Hi-Dow Wireless TENS/EMS System (Model HD-5N)
    K Number
    K163393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hi-Dow International, Inc.
    Date Received
    December 2, 2016
    Decision Date
    August 4, 2017
    Product Code
    NUH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    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 Hi-Dow International, Inc.

    K Number Device Name
    K233461 Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
    K210383 Wrap Accessory Electrodes
    K202337 Pulsed electromagnetic field wrap
    K190617 Wrap accessory electrodes
    K102598 HI-DOW-XP