Yuwell YE660E - Medaval

Description:

The Yuwell YE660E 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 Yuwell YE660E, to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also 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 claim without published evidence

Device Family:

Yuwell YE690A (V1)P, Yuwell YE660EP
Legend: P Stride Equivalence

Validation Publications:

Posokhov IN, Praskurnichiy EA, Orlova OS, Sukhodolova EA, Lystseva AV. Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less. Blood Press Monit. Epub: 2024 Jul 2. doi: 10.1097/MBP.0000000000000715. PMID: 38958495.

81060-2:2019 - Fail Small Cuff Size

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.

Yuwell YE690A (V1)

Chen Q, Lei L, Li Y, Wang JG. Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Oct;22(5):295-7. Epub: 2017 Jun 14. doi: 10.1097/MBP.0000000000000278. PMID: 28617717.

ESH-IP:2010 - Pass General population