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    K Number
    K161432
    Device Name
    MyNeWT Negative Pressure Wound Therapy System
    Manufacturer
    Stortford Medical LLC
    Date Cleared
    2017-02-08

    (260 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stortford Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The myNeWT system is indicted for patients who would benefit from Negative Pressure Wound Therapy as it may promote wound healing by removing low to moderate levels (< 37.5 ml/day) of exudate and infectious materials. Appropriate wound types include: - Chronic wounds - Acute, Sub-acute and dehisced wounds - Traumatic wounds - Partial thickness burns - Pressure or venous insufficiency ulcers - Diabetic ulcers - Flaps and grafts - Closed incision sites
    Device Description
    The myNeWT Negative Pressure Wound Therapy System is a portable, body worn, Single Use system for patients who have hard to heal wounds. Therapy is accomplished by the electronically controlled pump unit delivering a continuous negative pressure at -80 mmHg ±20mmHg to the wound surface, which draws the exudate into a flexible exudate canister, creating an environment that promotes wound healing via the removal of low to moderate amounts (<37.5ml/day) of exudate and infectious materials from the wound. When the canister is full it can be replaced without disturbing the wound bed or the wound dressing. This device is programmed to run for 7 days after the batteries are inserted, after which the device will not operate and will need to be replaced. The kit consists of :- - A battery operated vacuum pump, supplied with 2 x AA size Lithium batteries, - a flexible exudate canister with attached tubing, - a sterile wound interface kit. - a carrying bag with straps for the pump and canister. - User Manual - Quick Reference Guide Healthcare Professional - Quick Reference Guide - Patient It must be used with a commercially available wound dressing as selected by the Healthcare Professional based on the wound requirements or the physician's prescription. These dressings are NOT provided as part of the kit. A list of recommended dressings is provided in the user manual. The dressing must be applied and the myNeWT System set up by a Healthcare Professional skilled in wound care in accordance with the user manual.
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    K Number
    K090308
    Device Name
    RESTEP DVY SYSTEM, MODEL RSP-101
    Manufacturer
    STORTFORD MEDICAL LLC
    Date Cleared
    2009-05-01

    (84 days)

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

    STORTFORD MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Restep DVT System is a prescriptive device that helps stimulate blood flow in the deep veins of the legs and is intended for use in :- . Preventing Deep Vein Thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, neurology, urologic, critical care, general medicine obstetrics and general surgery.
    Device Description
    The Restep DVT System consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.
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