Grandway MD2231 (G.LAB)
Device Name:
G.LAB
Device Model:
MD2231
Manufacturer:
Distributer: Aceso Healthcare Products Inc. (G.LAB), 44364 South Grimmer Blvd., Fremont, CA 94538, UNITED STATES.
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Grandway MD2231 (G.LAB) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Grandway MD2231 (G.LAB), to measure blood pressure, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★★ Recommendation | Recent clinical validation; older protocol; multiple clinical validations |
| BP | BIHS (UK and IRL) | Self-measurement (Previous) | Published evidence |
| BP | Stride BP | Self-measurement for adults | Published evidence |
| BP | FDA (US) | 510(k) | 510(k) K133618 |
| BP | MDR Criteria | Self-measurement | Published evidence |
Validation Publications:
Jiao Y, Guan Q, Wu L, Wang C, Cao L. Validation of the G.LAB MD2231 digital automatic wrist blood pressure monitor according to multiple protocols. Blood Press Monit. 2017 Aug;22(4):226-9. Epub: 2017 Mar 21. doi: 10.1097/MBP.0000000000000256. PMID: 28328581.
ESH-IP:2010 - Pass General population
81060-2:2013 - Pass General population
BHS:1993 - Pass (A/A) General population