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510(k) Data Aggregation

    K Number
    K061125
    Device Name
    DVTCARE CA5
    Manufacturer
    DOCTORS ORDERS
    Date Cleared
    2006-05-23

    (29 days)

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

    DOCTORS ORDERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DVTcare™ CA5 is intended to be an easy to use, portable system that is prescribed by healthcare professionals, to help prevent the onset of DVT in patients, by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to: aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and swelling, reduce wound healing time, and aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
    Device Description
    The DVTcare™ CA5 system is a light weight, portable, prescriptive device that helps stimulate blood flow in the legs through the use of pneumatically controlled, single chamber leg cuff(s), actuated by an electronically controlled pump unit and solenoid valves. All pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 plastic quick disconnects for air tube connection, and an external power supply input jack. The option exists for the unit to be used in single leg or double leg modes. During operation, the pump unit provides air to one cuff through flexible plastic tubing, inflating it to a specified pressure, to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the current set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. To provide maximum flexibility, the CA5 also provides adjustable cycle times. System software prevents users from entering a cycle time, for any one limb, to be less than 60 seconds. This is done to prevent excessive stimulation of the limb. In single leg mode, this cycle repeats until the unit is turned off. In double leg mode the first and second leg cuffs do not fill simultaneously. The second leg begins its fill once the first leg has reached the midpoint of the overall cycle time for both legs. In double leg mode, air flow is directed to fill the second bladder cuff using the same cycle profile as the initial leg. After completing the fill, exhaust and rest period of leg 1, the control unit directs air flow to the second leg and fills that bladder cuff until the set pressure is reached and exhausted. The cycle repeats, reverting air flow to the initial leg. The control unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for mains connection.
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