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510(k) Data Aggregation

    K Number
    K250974

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (256 days)

    Product Code
    Regulation Number
    870.5800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K024019, K072666, K131146, K210417, K240499

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

    The Bio Arterial Deluxe Arterial Blood Flow Enhancement System is intended:

    • For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation
    • For treatment of patients with intermittent claudication, rest pain, diabetic foot, ischemic neuritis, arterial ulcers, gangrene, poor runoff
    • As an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: amputations (minor), angioplasty/stent failure, arteriopathic wounds, graft failure, intermittent claudication, ischemia, night pain, rest pain, small vessel disease, ulcers
    Device Description

    Bio Compression Systems' Bio Arterial Deluxe is a pneumatic compression device which consists of a pneumatic compression sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's sections ("chambers") in sequence from the distal end toward the trunk of the body. The inflation of the garment compresses the area of the body on which it is worn, stimulating blood flow.

    The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

    The pump is controlled by softkeys and an LED display.

    The device uses the Predicate Device's garments.

    AI/ML Overview

    N/A

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