Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

The Automatic Electronic Blood Pressure Monitor (U90B series) is a non-invasive upper-arm blood pressure monitor designed to measure systolic pressure, diastolic pressure, and pulse rate in individuals 12 years and older. It is intended for use in home or hospital settings and is not a diagnostic device. The device uses an inflatable cuff wrapped around the upper arm with an electronic pressure sensor.

The device employs the oscillometric method with an automatic internal pump for pressurization and standard exhaust valve for deflation. It has a measuring range of 0–299 mmHg with ±3 mmHg accuracy for pressure and ±5% for pulse. The cuff fits arm circumferences of 220–400 mm. Power is supplied by 4×AA batteries or Type-C 5V/2A, with operating temperature 5–40°C and humidity 15–93% RH.

The device conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, and ISO 10993-1 (biocompatibility). Clinical validation followed ISO 81060-2:2018 and ISO 81060-2:2018/Amd.2:2024 with 85 test subjects across gender, arm circumference, and blood pressure distributions.

The U90B series is substantially equivalent to the predicate device (K243115, Upper Arm Electronic Blood Pressure Monitor) based on identical intended use, same oscillometric measurement principle, same inflation/deflation methods, same materials, and same manufacturing facility. Minor differences in cuff size (220–400 mm vs. 220–420 mm), power supply options (added Type-C), and operating humidity range do not raise safety or effectiveness concerns and have been validated per applicable standards.