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

    SHIATSU MASTER MASSAGER CUSHION

    K Number: K952916 · Decision Aug 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    64
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    SHIATSU MASTER MASSAGER CUSHION
    K Number
    K952916
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kinsei Shiatsu, Inc.
    Date Received
    June 26, 1995
    Decision Date
    August 28, 1995
    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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