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

    RIFTON MOR219 19 & RIFTON MOR225 25

    K Number: K921817 · Decision Apr 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    34
    Applicant Total
    7
    Review Days
    14

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    Basic Information

    Device Name
    RIFTON MOR219 19 & RIFTON MOR225 25
    K Number
    K921817
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rifton Equipment For the Handicapped
    Date Received
    April 15, 1992
    Decision Date
    April 29, 1992
    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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    Other Clearances by Rifton Equipment For the Handicapped

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    K892698 E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER
    K892700 E65 35 PRONE STANDER
    K892699 E613 PAIR OF SUPPORT BLOCKS