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510(k) Data Aggregation

    K Number
    K113525
    Device Name
    ACTIVECARE DVT ACTIVECARE+SFT
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2012-01-31

    (63 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiveCare DVT and ActiveCare+SFT Systems are prescription devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. The Systems are intended for use in: - Preventing Deep Vein Thrombosis (DVT). - Enhancing blood circulation. - Diminishing post-operative pain and swelling. - Reducing wound-healing time. - Treatment and assistance in healing: stasis dermatitis: venous stasis ulcers: arterial and diabetic leg ulcers. - Treatment of chronic venous insufficiency. - Reducing edema.
    Device Description
    The ActiveCare DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve, The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
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    K Number
    K023573
    Device Name
    WIZAIR COMPRESSION SYSTEM
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2002-11-21

    (28 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.
    Device Description
    The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVT™ provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot -- single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh -- single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.
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    K Number
    K002287
    Device Name
    WIZAIR COMPRESSION SYSTEM
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2000-08-25

    (29 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993758
    Device Name
    PROAIR 3000 COMPRESSION SYSTEM
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2000-05-19

    (196 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProAir 3000 is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ProAir 3000 is intended for use by patients and medical professionals in treating many conditions, such as: prevention of deep vein thrombosis (DVT), enhancement of blood circulation, reduction of post-operative pain and swelling, reduction of wound-healing time, stasis dermatitis, treatment and assist healing of cutaneous ulceration, venous stasis ulcers, leg ulcers, chronic venous insufficiencies, reduction of edema.
    Device Description
    The ProAir 3000 is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The device is composed of four components: Portable pneumatic control unit, Pair of cuffs (calf and/or foot-ware), Pneumatic connecting tubes, Electrical transformer. During the compression cycle the solenoid valves are activated to insert air into one cuff and then other valves are activated for the other cuff. After inflating the cells in one cuff, the solenoid valves are deactivated and, simultaneously, the second cuff is inflated. Following a complete cycle for both legs there is a relaxation period. A software-based protection limits the pressure in all cuff cells using pressure sensors. In addition, a mechanical valve has been included in the air system for releasing air in case of over pressure in one of the cells. The ProAir 3000 has three operation modes: calf cuff mode, foot cuff mode and combined mode.
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    K Number
    K994057
    Device Name
    SLENDAIR 4000 COMPRESSION SYSTEM
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
    Date Cleared
    2000-03-03

    (94 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SlendAir 4000 is a prescriptive device that induces controlled compression of the leg or the arm. The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as: Primary lymphoedema, Post mastectomy edema, Leg ulcers, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphoedema.
    Device Description
    The SlendAir 4000 is a prescriptive, pneumatic compression device designed to apply peristaltic compression to a limb. The device is composed of four components: Light and portable pneumatic control unit, Calf, foot, full leg, or full arm cuff composes of 1-12 cells, Pneumatic connecting tubes, Electrical transformer. The SlendAir enables different treatment pressures (30-90mmHg) and treatment times (15-60 minutes) that should be used according to physician discretion. When activated, air flows into the cuff cells in a continues, predetermined peristaltic waveform. A mechanical valve has been included in the air system for releasing air in case of over pressure in one of the compartments.
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