BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    HIVOX OTC Electrical Stimulator

    K Number: K190347 · Decision Mar 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    18
    Review Days
    29

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    Basic Information

    Device Name
    HIVOX OTC Electrical Stimulator
    K Number
    K190347
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hivox Biotek, Inc.
    Date Received
    February 14, 2019
    Decision Date
    March 15, 2019
    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 Hivox Biotek, Inc.

    K Number Device Name
    K260425 TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
    K242815 POCKET TENS (EP-300)
    K232675 Heating Tens, FT-615
    K223308 HEATING TENS/EMS, FT-810R
    K221384 Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
    K211403 HIVOX OTC Electrical Stimulator, FT610-B
    K203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
    K192264 HIVOX Spopad EMS SP-911, SP-921
    K171803 HIVOX OTC Electrical Stimulator
    K143737 EM25 - glute toning device
    Search all 18 clearances from Hivox Biotek, Inc. →