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510(k) Data Aggregation

    K Number
    K151290
    Device Name
    Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff
    Manufacturer
    XUZHOU MAICUFF TECHNOLOGY CO.,LTD.
    Date Cleared
    2015-06-30

    (46 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    XUZHOU MAICUFF TECHNOLOGY CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 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 neonatal, pediatric and adult sizes. The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in infant, pediatric and adult sizes.
    Device Description
    The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 18 models with different size for different population with different arm size, and the 9 models of 18 are use single tube of air hose and other 9 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 10 models with different size for different population with different arm size, and the 5 models of 10 are use single tube of air hose and other 5 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. Both disposable and reusable blood pressure cuff are provided as non-sterile.
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