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    K Number
    K153251
    Device Name
    Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
    Manufacturer
    NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD.
    Date Cleared
    2016-04-14

    (156 days)

    Product Code
    DXQ,DXO
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K151290,K120364
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    Device Name :

    Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff

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

    The Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in infant, pediatric and adult sizes. They are used in hospital settings.

    Device Description

    "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are an accessory used in conjunction with noninvasive blood pressure measurement systems. They incorporate an inflatable nondistensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation, for the purpose of occlusion of an artery. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" have a structure which contains Cuff with bladder and Air Hose. Air hose has either single tube or double tubes." The device is secured by hook and loop closure onto the patient limb. It has two variations: TS-101S" is the variant that has single tube structure, while "TS-101D" is the variant that has double-tube structure. The cuff is made from non-woven fabrics, the air hose and tubes are made from polyvinyl chloride. Therefore, the non-woven fabric (cuff) is the material used to contacting with the patient. "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are single use device and are provided as non-sterile. They are available in infant, pediatric and adult sizes. "Tenso TS-101S Disposable Blood Pressure Cuffs" (single tube model) have 6 models with different size for different population with different arm size. "TS-101D Disposable Blood Pressure Cuffs" (double tube model) also have 6 models with different size for different population with different arm size.

    AI/ML Overview

    Acceptance Criteria and Study for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff

    This document describes the acceptance criteria and the study performed to demonstrate that the Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs meet these criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicSpecification (Acceptance Criteria)Reported Device Performance (Results)
    Mechanical StrengthAble to withstand 300 mm HgMeet
    Fatigue StrengthAble to withstand inflation (to 300 mm Hg) and deflation for at least 300 timesMeet
    Leakage RateLeakage rate
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