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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 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 MD2200-W (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 AssessmentRecommendationBasis
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) 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