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

    FLEXION-BRAKING KNEE-SHIN ASSEMBLY

    K Number: K761314 · Decision Jan 10, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    248
    Registration Numbers
    248
    Same Product Code
    42
    Applicant Total
    9
    Review Days
    18

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    Basic Information

    Device Name
    FLEXION-BRAKING KNEE-SHIN ASSEMBLY
    K Number
    K761314
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5370
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hosmer Dorrance Corp.
    Date Received
    December 23, 1976
    Decision Date
    January 10, 1977
    Product Code
    ION
    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
    ION Exerciser, Non-Measuring

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