Grandway MD2200-W (G.LAB)

Device Name:

G.LAB

Device Model:

MD2200, MD2200-W

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 MD2200-W (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 MD2200-W (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) K142088
BP	MDR Criteria	Self-measurement	Published evidence

Device Family:

Grandway MD2200-W (G.LAB)Z, Grandway MD2200-BKZ
Legend: Z Almost Certain

Validation Publications:

Liu ZY, Zhang QH, Ye XL, Liu DP, Cheng K, Zhang CH, Wan Y. Validation of the G.LAB MD2200 wrist blood pressure monitor according to the European Society of Hypertension, the British Hypertension Society, and the International Organization for Standardization Protocols. Blood Press Monit. 2017 Apr;22(2):101-4. Epub: 2017 Feb 7. doi: 10.1097/MBP.0000000000000234. PMID: 28177942.

ESH-IP:2010 - Pass General population

81060-2:2013 - Pass General population

BHS:1993 - Pass (A/A) General population