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

    RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)

    K Number: K951560 · Decision Apr 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    5
    Review Days
    12

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    Basic Information

    Device Name
    RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
    K Number
    K951560
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Radius Intl., Inc.
    Date Received
    April 5, 1995
    Decision Date
    April 17, 1995
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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    Other Clearances by Radius Intl., Inc.

    K Number Device Name
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    K972025 RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
    K971901 RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
    K930510 RADIUS ENTERAL FEEDING TUBE