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510(k) Data Aggregation

    K Number
    K121106
    Device Name
    TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
    Manufacturer
    SURGICAL APPLIANCE INDUSTRIES, INC.
    Date Cleared
    2012-04-27

    (15 days)

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

    SURGICAL APPLIANCE INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUFORM® Ready-To-Wear Compression Arm Sleeve is intended to be used to apply pressure to the upper extremity and is indicated for use in the management of mild to moderate Lymphedema and other edema, phlebitis, post-thrombotic syndrome and vascular malformations. The TRUFORM® Ready-To-Wear Compression Gauntlet is intended to be used to apply pressure to the hand and wrist and is indicated for use in the management of Lymphedema and other edema.
    Device Description
    The TRUFORM® Ready-To-Wear Compression Arm Sleeve is circular knit with nylon and spandex yarns, is available in 3 sizes -- small, medium, and large, and is latex free, air-permeable and available in beige, black and brown. The sizing of the TRUFORM® Ready-To-Wear Compression Arm Sleeve is based on circumferential measurements taken around the smallest part of the wrist, mid-lower arm, and around the mid-upper arm and is limited to individuals that fall within those specified ranges. The TRUFORM® Ready-To-Wear Compression Gauntlet is circular knit with nylon and spandex yarns, is available in 3 sizes - small with compression of 15- 20 mmHg, medium with compression of 20-30 mmHg and large with compression of 20-30 mmHg. The thumb piece is sewn in place during a second operation. The TRUFORM® Ready-To-Wear Compression Gauntlet is latex free, air-permeable and available in beige, black and brown. The sizing of the TRUFORM® Ready-To-Wear Compression Gauntlet is based on circumferential measurements taken around the palm and around the smallest part of the wrist, and is limited to individuals that fall within those specified ranges in sizing chart.
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