BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ERGOSEAT SYSTEM

    K Number: K954162 · Decision Oct 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    55

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    Basic Information

    Device Name
    ERGOSEAT SYSTEM
    K Number
    K954162
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ergo-Air, Inc.
    Date Received
    September 5, 1995
    Decision Date
    October 30, 1995
    Product Code
    MOC
    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
    MOC Cushion, Flotation, Therapeutic

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    Other Clearances by Ergo-Air, Inc.

    K Number Device Name
    K952092 ERGOMAT 8000 SYSTEM
    K952093 ERGOMAT 5000 SYSTEM