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510(k) Data Aggregation

    K Number
    K141127
    Device Name
    MEDLINE ANTI-EMBOLISM STOCKING
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2014-08-21

    (112 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Designed to apply controlled pressure to the leg to promote increased blood flow velocity. For use in prevention of deep vein thrombosis (DVT).
    Device Description
    Not Found
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    K Number
    K131496
    Device Name
    BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
    Manufacturer
    BSN MEDICAL, INC.
    Date Cleared
    2013-07-10

    (48 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema
    Device Description
    Not Found
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    K Number
    K123820
    Device Name
    BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
    Manufacturer
    BOSSONG HOSIERY MILLS, INC
    Date Cleared
    2013-04-02

    (111 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    8-15 mmHg Mild For tired, aching legs, minor leg swelling, leg pain, poor blood circulation 8 10-20 mmHg Anti-Embolism Stocking - Helps prevent edema and leg discomfort, and helps prevent deep vein thrombosis (DVT) in patients subjected to immobility. 15-20 mmHg Moderate Firm - For mild varicose veins, post surgery, poor blood circulation, leg discomfort, mild to moderate swelling, tired and aching legs - Helps prevent deep vein thrombosis for long distance travelers and edema 20-30 mmHg - For varicose veins, post surgery, venous insufficiency, moderate to severe varicosis, moderate swelling - Helps prevent deep vein thrombosis for long distance travelers and edema 30-40 mmHg Extra Firm - For edema, after healing of leg ulcers, severe chronic venous insufficiency, postphlebitic syndrome, post deep vein thrombosis (DVT), advanced varicose veins, phlebitis and reversible lymphedema - Post varicose vein surgery, vein stripping, sclerotherapy, plebectomy
    Device Description
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    K Number
    K123085
    Device Name
    FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
    Manufacturer
    3M COMPANY
    Date Cleared
    2012-12-20

    (80 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel. Over the counter use.
    Device Description
    The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are made of a blend of nylon and spandex. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose provide graduated compression of the leg, with the higher compression in the ankle region and lower compression in the calf and the thigh (for the pantyhose only). Two compression ranges are available. Moderate. 15-20 mmHg. and Firm. 20-30mmHg. The compression hosiery products are produced on circular knitting machines. Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are substantially equivalent to the predicate products in product materials, mode of action, compression levels, function and indication for use, and as such, can be considered safe and effective as the referenced, predicate products. Like the products, the FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are available in a variety of colors and sizes for both men and women. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose differ from the predicate devices in the following aspects. Tsung Hau Technology Company, Limited, Shape to Fit, compression hosiery utilizes a "fresh weave odor control". The 3M FUTURO™ hosiery does not. Jobst's Travel Sock contains cotton yarn for comfort. The 3M FUTURO™ hosiery does not contain any cotton (with the exception of the cotton lined crotch in the pantyhose). No other significant differences are noted.
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    K Number
    K123398
    Device Name
    DR. SCHOLL'S COMPRESSION SOCKS
    Manufacturer
    RENFRO CORPORATION
    Date Cleared
    2012-12-18

    (43 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Renfro Compression Socks are intended to help prevent pooling of blood in the legs by controlled pressure in the legs and help prevent deep vein thrombosis (DVT), edema and leg discomfort in individuals subjected to immobility
    Device Description
    The Renfro Compression Socks are devices intended to help prevent pooling of blood and fluid to the extremities by applying controlled pressure. The Renfro compression socks are knitted using yarns made of nylon, polyester, cotton and spandex.
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    K Number
    K123561
    Device Name
    ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
    Manufacturer
    BSN MEDICAL, INC.
    Date Cleared
    2012-12-18

    (29 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of lymphedema and other edema.
    Device Description
    Not Found
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    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
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    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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    K Number
    K112769
    Device Name
    CURAD COMPRESSION HOSIERY
    Manufacturer
    MEDLINE, INDUSTRIES, INC.
    Date Cleared
    2012-03-01

    (160 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curad Compression Hosiery is intended for use in helping prevent edema and leg discomfort, and helping prevent deep vein thrombosis (DVT) in individuals subjected to immobility. 15-20mmHg: Helps to prevent edema and leg discomfort, and helps to prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Especially for long distance travelers and those on their feet for extended periods of time. 20-30mmHg: Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs. 30-40mmHg: Helps to prevent edema and leg discomfort and helps to prevent deep vein thrombosis.
    Device Description
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    K Number
    K111662
    Device Name
    VENOTRAIN CURAFLOW
    Manufacturer
    BAUERFEIND AG
    Date Cleared
    2011-10-04

    (112 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VenoTrain curaflow compression garments are intended to be used to apply pressure to the extremities and are indicated for use in management of lymphedema and other edematous conditions, phlebitis, and vascular disorders.
    Device Description
    The VenoTrain curaflow compression garments help to prevent pooling of blood and fluid in the extremities by applying controlled pressure. The VenoTrain garments are flat knit using yarns made of nylon and spandex and then sewn together.
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    K Number
    K101614
    Device Name
    HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
    Manufacturer
    DM SYSTEMS, INCORPORATED
    Date Cleared
    2011-01-13

    (218 days)

    Product Code
    DWL
    Regulation Number
    880.5780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To prevent the pooling of blood and deep vein thrombosis in the legs. For patients at risk of developing compromised or inadequate venous return from the legs as a result of both medical and non-medical circumstances. The HeelSafe DVT Hose are designed to aid and prevent deep vein thrombosis in the recumbent patient with limited mobility. Progressive compression from foot to knee aids in improving venous return and avoiding clot formation.
    Device Description
    The HeelSafe DVT Hose open heel aids in preventing pressure on the heel that could be caused by the additional 15-18 mm Hg of pressure of other compression stockings. The HeelSafe DVT Hose open heel allows for easy visualization and palpation of the heel at all times.
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