Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

The Electronic Sphygmomanometers (models ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) are automated, non-invasive blood pressure monitors intended to measure systolic and diastolic pressure in adults and adolescents aged 18–21 years for home use. The device is contraindicated in pregnant women, including those with preeclampsia.

The proposed device uses oscillometric measurement with arm circumference range 22–42 cm, pressure accuracy of ±3 mmHg (±0.4 kPa) or 2% of reading, and LCD display with mmHg/kPa unit selection. It stores 2×99 sets of measurement data, operates on 4 AAA batteries (DC 6V) or optional USB adapter, and includes optional Bluetooth transmission capability. The predicate device has similar specifications but narrower cuff range (22–32 cm) and lacks Bluetooth.

IEC 80601-2-30 (automated non-invasive sphygmomanometers), ISO 81060-2 (clinical validation of automated measurement type), ANSI AAMI ES 60601-1, IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-11 (home healthcare environment), ISO 10993-5/-10/-23 (biocompatibility), and FCC Part 15 Subpart C (RF emissions).

The proposed device and predicate (K191894) share identical intended use, oscillometric measurement principle, accuracy specifications, display type, memory function, and general operating environment parameters. Although the proposed device has a wider cuff circumference range (22–42 cm vs. 22–32 cm), optional Bluetooth capability, and modified appearance across seven models, the applicant demonstrates these differences fall within the scope of existing cleared reference devices and do not affect safety or effectiveness. Comparative clinical testing per ISO 81060-2 showed significant correlation between the proposed and predicate devices.