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

    WINDMERE PRELUDE III

    K Number: K924237 · Decision Oct 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    7
    Review Days
    420

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    Basic Information

    Device Name
    WINDMERE PRELUDE III
    K Number
    K924237
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Windmere Corp.
    Date Received
    August 24, 1992
    Decision Date
    October 18, 1993
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

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