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510(k) Data Aggregation

    K Number
    K250765
    Manufacturer
    Date Cleared
    2025-09-03

    (174 days)

    Product Code
    Regulation Number
    870.1120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The cuff is compatible with non-invasive blood pressure monitors to measure blood pressure.

    It is intended for use by healthcare professionals (prescription use) and by laypersons in home settings (over-the-counter use).

    The cuff is designed for adult patients. It is non-sterile and reusable.

    Device Description

    The primary components of the AViTA blood pressure cuff include an inflatable bladder and an outer fabric layer with a hook-and-loop fastening system. The cuff is designed to wrap securely around the patient's upper arm, allowing for accurate measurement of blood pressure when used with AViTA blood pressure monitors.

    The AViTA blood pressure cuffs are available in five different sizes to accommodate a range of arm circumferences:

    ModelLimb Range (Unit: cm)
    6NRUI-K22-42 cm
    6NRLI-K33-42 cm
    6NRXI-K42-52 cm
    6NRSI-K15-22 cm
    6NRMI-K22-33 cm

    During operation, the cuff inflates and deflates to occlude and release arterial blood flow, utilizing the oscillometric method to detect systolic and diastolic pressure. The cuff is constructed with durable materials to withstand repeated inflation cycles and ensure long-term performance.

    The AViTA blood pressure cuff is designed for compatibility with AViTA blood pressure monitors, ensuring optimal performance and measurement accuracy.

    AI/ML Overview

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