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510(k) Data Aggregation

    K Number
    K070457
    Device Name
    SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
    Manufacturer
    SUN SCIENTIFIC LLC
    Date Cleared
    2007-05-16

    (89 days)

    Product Code
    MHW
    Regulation Number
    880.5075
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist in the management of venous stasis ulcers by applying pressure.
    Device Description
    The device includes a Leg Compressor and a Pre-Filled Air Bladder (PFAB). The PFAB does not apply pressure, but when it is used in conjunction with a compression bandage, it will exert local pressure (because of the air pocket). Compression bandages exert pressure, therefore the pre-filled air bladder will redistribute the pressure that the bandage would already by supplying. Overall the device is meant to redistribute and apply pressure to the venous ulcer. It has been found over the years that compression bandages or stockings healed more venous leg ulcers than no compression. If the venous ulcer is kept covered and clean with applied pressure the healing process is more effective. The concept behind this device is to keep the wound covered and apply pressure on the wound. #### PFAB (Pre-Filled Air Bladder) The PFAB is an oval shaped polyurethane pre-filled air bladder with four flanges. The tips of the flanges have medical adhesive, which adheres to the skin. The bottom of the PFAB has medical grade hydrophilic foam, which will cover the ulcer and is used to absorb the exudates. The PFAB will be offered in three sizes (Small, Medium, and Large). #### Leg Compressor The leg compressor is used to hold the PBAB in place and apply additional pressure. The leg compressor contains an air chamber that is made of 2 layers of urethane film. The outer black fabric is Nylon. The leg compressor also has a self adjusting manometer attached to the outside to measure the pressure within the air bladder, which will be situated along the Great Saphenous Vein. The manometer is used for reference only and is not meant to be used for accurate measurements of pressure. The Leg Compressor includes a safety release valve to deflate the compressor. In addition, the manometer is color coded. As a precaution the user should not inflate the compressor in the red zone. The pressure at the beginning of the red zone is approximately 30 mm Hg, which is similar to the pressure from a typical Umma Boot or compression bandage.
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    K Number
    K040936
    Device Name
    PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
    Manufacturer
    LEDA CO., LTD.
    Date Cleared
    2004-05-03

    (24 days)

    Product Code
    FQM
    Regulation Number
    880.5075
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
    Device Description
    The Petit Silma Elastic Bandage is a simple device to provide relief of minor physical discomforts arising from stress or strain of repetitive actions including athletic, workplace and at-home activities. It consists of an elastic compression bandage, containing the element Germanium in a circular pellet. The product is worn on the injured portion of the body (elbow, knee, wrist) as appropriate. Alternatively, a second version of the the product would contain a Titanium Oxide pellet, instead of Germanium.
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    K Number
    K040054
    Device Name
    BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
    Manufacturer
    THEODORE BARASH
    Date Cleared
    2004-04-27

    (106 days)

    Product Code
    FQM
    Regulation Number
    880.5075
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
    Device Description
    (a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.
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    K Number
    K013244
    Device Name
    COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
    Manufacturer
    MED GEN, INC.
    Date Cleared
    2001-12-07

    (70 days)

    Product Code
    FQM
    Regulation Number
    880.5075
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in strenuous or intense physical activities associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and at-home activities. Device provides support for relief of discomfort in self-limiting physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation. ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.
    Device Description
    (a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew
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    K Number
    K013239
    Device Name
    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
    Manufacturer
    MED GEN, INC.
    Date Cleared
    2001-11-20

    (53 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation. ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.
    Device Description
    (a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.
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    K Number
    K980563
    Device Name
    SKAR-KARE SHEET
    Manufacturer
    LIFE MEDICAL SCIENCES, INC.
    Date Cleared
    1998-05-20

    (96 days)

    Product Code
    MDA
    Regulation Number
    878.4025
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.
    Device Description
    SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.
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