AViTA Arm Type Blood Pressure Monitor Cuff

The AViTA Arm Type Blood Pressure Monitor Cuff is a reusable, non-sterile accessory designed for adult patients that wraps around the upper arm to measure blood pressure when used with non-invasive blood pressure monitors. It is intended for use by both healthcare professionals in clinical settings and by patients in home settings, and is available in five sizes covering arm circumferences from 15–52 cm.

The device features an inflatable bladder with an outer fabric layer and hook-and-loop fastening system. It has been tested for durability to withstand 10,000 inflation cycles and 3,000 hook-and-loop closures. The cuff operates via the oscillometric method and maintains a pressure range of 0–330 mmHg with maximum leakage less than 4 mmHg/min, identical to the predicate device.

ISO 81060-1 (non-automated sphygmomanometer requirements), ISO 81060-2:2018 (clinical validation protocol), ISO 10993-1 (biological evaluation framework), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation testing).

Both devices use identical operating principles (oscillometric measurement via inflatable bladder and hook-and-loop closure), regulation, and classification. The subject device covers the full adult arm circumference range (15–52 cm) with five cuff sizes and has demonstrated clinically validated accuracy meeting ISO 81060-2:2018 criteria. While the predicate includes neonatal, infant, and child sizes and the subject is adult-only, this narrower population does not raise new safety or effectiveness concerns. The subject device's additional ISO 10993-23 biocompatibility testing and documented durability testing (10,000 inflations, 3,000 closures) enhance rather than diminish safety, and the expansion to over-the-counter labeling does not alter fundamental technology or performance.