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

    THE BODY BUGGY

    K Number: K915361 · Decision Dec 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    THE BODY BUGGY
    K Number
    K915361
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innova Corp.
    Date Received
    November 27, 1991
    Decision Date
    December 20, 1991
    Product Code
    LYG
    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
    LYG Massager, Therapeutic, Manual

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