Misure MI Med 4 (F1102T)

Description:

The Misure MI Med 4 (F1102T) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Misure MI Med 4 (F1102T), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement for adults (Preferred)	Equivalence to the Jamr F1701T claim without published evidence

Device Family:

Jamr F1701TP, Misure MI Med 4 (F1102T)P, Novama White A+P, Vitammy Next E1P
Legend: P Stride Equivalence

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Jamr F1701T

Li J, Han LH, Feng R, Wu LH, Cai J, Zeng TY, Liu H, Zeng YW, Zhou L, Zhan ZQ. Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol. Blood Press Monit. 2023 Jun 1;28(3):163-166. Epub: 2023 Mar 7. doi: 10.1097/MBP.0000000000000643. PMID: 37016972. Available from: PMC10132453.

81060-2:2018 - Pass (n=90)