Grandway MD2301

Device Model:

MD2301

Manufacturer:

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:

Not made available

Description:

The Grandway MD2301 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 upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Grandway MD2301, 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	ESH (Europe)	Self-measurement	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence
BP	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Chen W, Zeng ZL, Bing S, Li LY, Wang R, Wan Y Validation of the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol Blood Press Monit. 2016 Aug;21(4):259-261. doi: 10.1097/MBP.0000000000000191. PMID: 27093703.

ESH-IP:2010 - Pass General population

Huang J, Wang Y, Liu Z, Wang Y. Simultaneous validation of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation/the International Organization for Standardization protocols. Blood Press Monit. 2017 Feb;21(1):44-47. doi: 10.1097/MBP.0000000000000218. PMID: 27749334.

81060-2:2013 - Pass General population

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