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510(k) Data Aggregation

    K Number
    K213313
    Device Name
    Veinoflow SCD (Model: LBTK-M-I 5006)
    Date Cleared
    2022-02-09

    (128 days)

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

    **Dalian Labtek Science **& Development Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.
    Device Description
    Veinoflow SCD, Model LBTK-M-I 5006, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① leg garments, ② calf garments, ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhancing the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value is preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.
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    K Number
    K123830
    Device Name
    INTERMITTENT PNEUMATIC COMPRESSION DEVICE
    Date Cleared
    2013-08-16

    (247 days)

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

    **DALIAN LABTEK SCIENCE **& DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Veinoflow SCD system, Model LBTK-M-1 5001 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5001 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.
    Device Description
    Veinoflow SCD, Model LBTK-M-I 5001, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① thigh-calf garments, ② calf garments, and ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhance the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value and inflatable interval time are preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.
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    K Number
    K121718
    Device Name
    A-V FOOT PUMP
    Date Cleared
    2012-08-17

    (67 days)

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

    **DALIAN LABTEK SCIENCE **& DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A-V Hand & Foot Pump, Model LBTK-M-I 1000, is intended for use to enhance blood circulation in the arteries and veins in patents. The indications vary depending on whether pump is used with the foot pad or hand pad. A. Foot use - Acute Edema - Chronic Edema - Circulation Enhancement - Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis - Leg Pain Incident to Trauma or Surgery - Leg Ulcers - Venous Stasis/Venous Insufficiency B. Hand use - Acute Edema - Chronic Edema - Circulation Enhancement - Pain Incident to Trauma or Surgery
    Device Description
    A-V Hand & Foot Pump, Model LBTK-M-I 1000, consists of a pump controller connected by air supply hoses to specially designed inflation pads. The pump controller is microprocessor controlled, with a liquid crystal display, power switch, two air output sockets, function keys of "Left impulse run/pause", "Pressure adjustment", "Left preset settings", "Increase key-press", "Decrease key-press", "Right preset settings", "Impulse interval control", "Right Impulse run/pause", and so on. The pulse pressure, pulse duration, and pulse interval can be displayed by the screen. The inflation pads include foot pad, hand pad and undercast foot pad. The pads have one air chamber, through which the air energy is transferred to the body. The pads are non-sterile and for single patient use only. The inflation pad is rapidly inflated by a controlled impulse of air from the controller. After each impulse the controller automatically allows the inflation pad to deflate. To deliver the impulse pressure effectively to the extremity, the inflation pad must be retained in the correct position. The system has built-in alarms and displays to alert attention to adjustment requirements and to assist with rapid troubleshooting.
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