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510(k) Data Aggregation

    K Number
    K250190

    Validate with FDA (Live)

    Date Cleared
    2025-12-08

    (319 days)

    Product Code
    Regulation Number
    870.5800
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SCD600 Sequential Compression System (hereby referenced as "SCD600") is designed to increase the flow rate of the patient's venous blood in order to prevent deep vein thrombosis and pulmonary embolism and treat limb edema via intermittent pneumatic compression. The SCD600 is intended for use only in professional healthcare facilities by medical staff as part of a prescribed plan of care.

    Device Description

    The subject device Sequential Compression System includes 1 model: SCD600.

    SCD600 Sequential Compression System is designed to apply intermittent pneumatic compression to increase the flow rate of the patient's venous blood, thereby helping prevent the occurrence of deep vein thrombosis, pulmonary embolism and treat limb edema in professional healthcare facility.

    The system consists of the main unit, connecting tubes, battery, AC power cord and accessory compression cuffs. The compression cuffs can increase the venous blood flow by compressing the limbs. When one compression is completed, the system will start the next compression after waiting the predetermined venous fill time.

    AI/ML Overview

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