BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

    QI GONG MASSAGER

    K Number: K955250 · Decision Feb 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    QI GONG MASSAGER
    K Number
    K955250
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    East Health Development Group, Inc.
    Date Received
    November 13, 1995
    Decision Date
    February 8, 1996
    Product Code
    IRO
    Advisory Committee
    Physical Medicine
    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
    IRO Vibrator, Therapeutic

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