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

    HI-DOW-XP

    K Number: K102598 · Decision May 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    6
    Review Days
    245

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    Basic Information

    Device Name
    HI-DOW-XP
    K Number
    K102598
    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
    September 10, 2010
    Decision Date
    May 13, 2011
    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

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    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
    K163393 Hi-Dow Wireless TENS/EMS System (Model HD-5N)