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

    U-WAY QUICKOLLAR

    K Number: K823247 · Decision Nov 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    297
    Registration Numbers
    297
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    U-WAY QUICKOLLAR
    K Number
    K823247
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Ems Industries, Inc.
    Date Received
    November 1, 1982
    Decision Date
    November 16, 1982
    Product Code
    IQK
    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
    IQK Orthosis, Cervical

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