Device Model:
YE660F
Manufacturer:
Jiangsu Yuyue Medical Equipment and Supply Co. Ltd. (Yuwell), Yunyang Industrial Park, Danyang, Jiangsu 212300, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Yuwell YE660F 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 YE660F, 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 Yuwell YE660D (V2) claim without published evidence |
Device Family:
Yuwell YE620BP,
Yuwell YE660D (V2)P,
Yuwell YE620A (V2)P,
Yuwell YE620ARP,
Yuwell YE620CP,
Yuwell YE620CRP,
Yuwell YE650ARP,
Yuwell YE650CRP,
Yuwell YE655A (V3)P,
Yuwell YE655B (V2)P,
Yuwell YE655D (V2)P,
Yuwell YE660FP,
Yuwell YE670A (V2)P,
Yuwell YE670CR (V2)P,
Yuwell YE620FP,
Yuwell YE650C (V3)P,
Yuwell YE650FP,
Yuwell YE655ARP,
Yuwell YE655C (V3)P,
Yuwell YE655CRP,
Yuwell YE660AP,
Yuwell YE660ARP,
Yuwell YE666CR (V2)P,
Yuwell YE680ARP,
Yuwell YE690AR (V2)P,
Yuwell YE690F (V2)P,
Yuwell YE630EPLegend:
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.
Yuwell YE660D (V2)
Zhang HJ, Peng Y, Zhang J, Zhang J, Teng LN, Zhang SJ, Zhou DJ, Long MZ. Validation of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) and the International Organization for Standardization Amendment 1. 2020. Blood Press Monit. 2023 Oct 1;28(5):276-279. Epub: 2023 Jun 22. doi: 10.1097/MBP.0000000000000658. PMID: 37382148.
81060-2:2020 - Pass General population (Note: Two cuffs 22-32 cm (standard) and 22-45 cm (wide range))
