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

    ROHO HEEL PAD

    K Number: K861327 · Decision Jun 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    54

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    Basic Information

    Device Name
    ROHO HEEL PAD
    K Number
    K861327
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3175
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Roho, Inc.
    Date Received
    April 9, 1986
    Decision Date
    June 2, 1986
    Product Code
    KIC
    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
    KIC Cushion, Flotation

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