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510(k) Data Aggregation

    K Number
    K210913
    Device Name
    V12 PRO
    Manufacturer
    SLK Medical GmbH
    Date Cleared
    2021-08-04

    (128 days)

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

    SLK Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    V12 PRO utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. V12 PRO consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has twelve (12) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body. The V12 PRO consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance, and a power cord. The user interface on the V12 PRO is a Membrane Keypad with dome switches. The settings are shown on a 3.2″ LCD Screen.
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    K Number
    K193476
    Device Name
    VariLymph 12 pro
    Manufacturer
    SLK Medical GmbH
    Date Cleared
    2020-08-19

    (247 days)

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

    SLK Medical GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)
    Device Description
    SLK Varilymph 12 Pro Compression Therapy Device utilizes a software-controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus, treat the symptoms of a variety of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main control contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and a rotating dis controlling air outflow. The regulated compressed air is transferred via an air distributor through a series of hoses to a sleeve garment. Each garment contains 12 pressure cells. The sleeve fits on the affected limb and can easily adjusted to any limb size within the sleeve tolerance. The devices are powered from a system supply voltage (230V / 110V). The SLK VariLymph 12 Pro (SLK V12 Pro) consist of an air compressor unit with a control system, an inflatable garment (arms, legs, trouser and jacket), silicon air tubing with proprietary connectors for connecting the device to the appliance; and a power cord. The user interface on the SLK VariLymph 12 Pro is a Membrane Keypad with dome switches. The settings are shown on a 3,2" LCD Screen. The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.
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