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510(k) Data Aggregation

    K Number
    K121376
    Device Name
    COMPRESSION CARE FLIGHT
    Manufacturer
    Date Cleared
    2012-07-24

    (77 days)

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

    MEDICAL MINDS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Compression Care Flight 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 (greater than 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 Compression Care Flight 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. 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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