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

    STONEHEART ROLLER AID

    K Number: K925247 · Decision Feb 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    STONEHEART ROLLER AID
    K Number
    K925247
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stoneheart, Inc.
    Date Received
    October 16, 1992
    Decision Date
    February 12, 1993
    Product Code
    INM
    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
    INM Chair, With Casters

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