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510(k) Data Aggregation

    K Number
    K234155
    Device Name
    Nimbl (model PD08-N1)
    Manufacturer
    Tactile Medical
    Date Cleared
    2024-06-21

    (175 days)

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

    Tactile Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nimbl system is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions: - Chronic edema - Lymphedema - Venous insufficiency - Wound healing
    Device Description
    The Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.
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    K Number
    K203178
    Device Name
    Flexitouch Plus System
    Manufacturer
    Tactile Systems Technology, Inc. (DBA Tactile Medical)
    Date Cleared
    2020-12-20

    (55 days)

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

    (DBA Tactile Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as - Lymphedema - Primary lymphedema - Post mastectomy edema - Edema following trauma and sports injuries - Post immobilization edema - Venous insufficiency - Reducing wound healing time - Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers - Lipedema - Phlebolymphedema The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema .
    Device Description
    The Flexitouch Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.
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    K Number
    K170216
    Device Name
    Flexitouch System
    Manufacturer
    Tactile Systems Technology, Inc (dba Tactile Medical)
    Date Cleared
    2017-05-26

    (122 days)

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

    Tactile Systems Technology, Inc (dba Tactile Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: - Lymphedema - Primary lymphedema - Post mastectomy edema - · Edema following trauma and sports injuries - · Post immobilization edema - · Venous insufficiency - · Reducing wound healing time · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
    Device Description
    The Flexitouch system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.
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    K Number
    K153311
    Device Name
    Flexitouch System
    Manufacturer
    TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
    Date Cleared
    2016-09-14

    (302 days)

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

    TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: - Lymphedema - Primary lymphedema - · Post mastectomy edema - · Edema following trauma and sports injuries - · Post immobilization edema - · Venous insufficiencies - · Reducing wound healing time · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
    Device Description
    The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.
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