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

    MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER

    K Number: K963480 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    6
    Applicant Total
    91
    Review Days
    141

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    Basic Information

    Device Name
    MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
    K Number
    K963480
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3910
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deroyal Industries, Inc.
    Date Received
    September 3, 1996
    Decision Date
    January 22, 1997
    Product Code
    KID
    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
    KID Restraint, Wheelchair, Non-Protective

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