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 3-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, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★★ Recommendation	Recent clinical validation; recent 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