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510(k) Data Aggregation

    K Number
    K032325
    Device Name
    JOBST TRAVEL SOCKS
    Manufacturer
    BSN-JOBST, INC.
    Date Cleared
    2003-08-28

    (31 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BSN-JOBST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jobst Travel Socks are indicated for the following conditions: Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers.
    Device Description
    Both products are manufactured on circular knit machines. Both products are made of nylon and spandex yarns and provide compression at the ankle of approximately 15-20mmHg. However, the JOBST Travel Socks also have cotton varns for added comfort. While both products are sized based on calf circumference, sizing information based on ankle circumference and shoe size will also be provided with the JOBST Travel Socks, for the convenience of the traveler. Compression is provided for these products by elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage, prevent pooling of blood and improve blood flow. Consequently, they act prophylactically to help reduce the risk of developing deep vein thromboses (DVT) and superficial thromboembolisms.
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    K Number
    K013852
    Device Name
    JOBST READY-TO-WEAR GAUNTLET
    Manufacturer
    BSN-JOBST, INC.
    Date Cleared
    2002-01-28

    (69 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    BSN-JOBST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jobst Ready-To-Wear Gauntlet may be used under the direction of a Healthcare professional to manage the flowing conditions: Edema Lymphedema Hypertrophic scars
    Device Description
    While the JUZO Gauntlet is flat knit and sewn together from fabric made of spandex, viscose and nylon yarns, the JOBST Ready-To-Wear Gauntlet is circular knit with spandex and nylon yarns. The thumb piece is then sewn in place in a second operation. Both products are available in two compression ranges, 20-30 mmHg and 30-40 mmHq. the compression ranges most often prescribed by physicians for the indications involved. Both products are sized based on the palm and wrist measurements. Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic absorption.
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