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510(k) Data Aggregation

    K Number
    K103187
    Device Name
    TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
    Manufacturer
    WILDCAT MEDICAL INC
    Date Cleared
    2011-01-26

    (90 days)

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

    WILDCAT MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TriplePlay-VT, model TPVT-01 (supplied with a pair of model TP-3333 "cuffs") is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: - Aid in the prevention of DVT; . - Enhance blood circulation; . - Diminish post-operative pain and swelling; . - . Reduce wound healing time; - 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. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
    Device Description
    The TriplePlay-VT Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device that is intended to be used by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valves. All pump, battery and control components are protectively housed in a plastic case. A mylar control panel overlays 4 tactile touch control switches, an LED display for monitoring pressure, LED "selected function", "low battery" and "charging" indicators. There is also a port for connecting the battery charger/AC adapter plug. The leg wrap (cuff), model TP-3333, consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from common kitchen sponge material, which is adhered to the PVC air bladder. The cuffs are supplied clean, non-sterile, packaged in pairs. One set of cuffs are supplied with the TPVT-01 system, and are also available as accessory items. In operation, the user selects either 1 of 5 different output modes (leg 1, leg 2, auxiliary, or a combination of leg 1 + auxiliary or leg 1 + leg 2 + auxiliary). An LED corresponding to each output indicates the selected modes. Appropriate single user "cuffs" containing air bladders are connected to the unit via externally accessible plastic quick-disconnect air ports. The control unit then fills the cuffs to a pre-determined pressure (50 mmHg for the leg cuffs, with the auxiliary cuff setting being adjustable between 20 and 50 mmHg - default setting of 35 mmHg is preset for the auxiliary function). The LED that corresponds to the activated cuff flashes slowly while that cuff is being filled with air. Cuff pressure is monitored by an integrated pressure transducer and system software. Once the pressure reaches the proper level, the pump is turned OFF for a predetermined "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the next cuff is sequenced, and so on. This cycle repeats until the unit is turned off. The "rest" period is internally preset to allow each cuff approximately 60 seconds between inflations in order to insure adequate relaxation time between compressions. When multiple cuff modes are selected, only one cuff is inflated at a time.
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