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The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated: Prescription Use, Part 21 CFR 801 Subpart D

Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and