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

    WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER

    K Number: K931086 · Decision Sep 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    211

    Basic Information

    Device Name
    WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER
    K Number
    K931086
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5975
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WINDMERE CORP.
    Date Received
    March 3, 1993
    Decision Date
    September 30, 1993
    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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