Grandway MD41A0 (G.LAB)

Device Name:

G.LAB

Device Model:

MD41A0

Manufacturer:

OBL: G.LAB, Zhukeng Community, Pingshan New District, Shenzhen, Guangdong Province, CHINA.

OEM: Grandway Healthcare Ltd., Room 1705, Kinox Centre, No. 9 Hung To Road, Kwun Tong, Kowloon, HONG KONG PRC.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Grandway MD41A0 (G.LAB) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Grandway MD41A0 (G.LAB), to measure blood pressure, has passed in two clinical validation studies, in pregnancy and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Recommended for pregnancy only	Validation in pregnancy
BP	Stride BP	Self-measurement for diabetes mellitus (Preferred)	Published evidence

Validation Publications:

Li LY, Tian L, Gao B, Ming J, Liu K, Jiang J, Han ZY, Zhao LY, Chen CS, Wan Y. Validation of the G.LAB MD41A0 upper arm blood pressure monitor in patients with diabetes mellitus according to the AAMI/ESH/ISO 81060-2: 2018 Universal Standard. Blood Press Monit. 2022 Aug 1;27(4):280-284. Epub: 2022 Mar 7. doi: 10.1097/MBP.0000000000000595.

81060-2:2019 - Pass Type 2 Diabetes Mellitus

Zhang Y, Shi Z, Liang H, Chen M, Sun Y, Shang F, Wan Y. Clinical Accuracy of the G.LAB MD41A0 Upper Arm Blood Pressure Monitor in Pregnancy and Pre-Eclampsia Using the AAMI/ESH/ISO as Reference Standard. Vasc Health Risk Manag. 2024 Nov 3;20:487-492. doi: 10.2147/VHRM.S479380. PMID: 39524156. Available from: PMC11549012.

81060-2:2019 - Pass Normotensive pregnancy (n=15), Hypertensive pregnancy (n=15), Pre-eclampsia (n=15) (Note: Overall results.)