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

    MOTOR MASSAGE PILLOW

    K Number: K912479 · Decision Aug 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    67

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    Basic Information

    Device Name
    MOTOR MASSAGE PILLOW
    K Number
    K912479
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Supreme Import , Ltd.
    Date Received
    June 3, 1991
    Decision Date
    August 9, 1991
    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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