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510(k) Data Aggregation

    K Number
    K012994
    Device Name
    WIZAIR DVT
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
    Date Cleared
    2002-03-27

    (202 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIZAIR DVT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.

    Device Description

    The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVTTM provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

    AI/ML Overview

    This document describes a 510(k) submission for the WizAir DVT™, a pneumatic compression device. The provided text, however, does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    The document primarily focuses on:

    • Device Description: What the WizAir DVT™ is and how it works.
    • Indications for Use: The medical conditions the device is intended to prevent or treat.
    • Contraindications: Situations where the device should not be used.
    • Regulatory Information: Classification, product code, applicant details, and the FDA's decision regarding substantial equivalence.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory clearance letter, not a clinical study report or a detailed performance validation document.

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