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Terumo ES-R800ST

Device Model:ES-R800ST
Manufacturer:Sole: Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.
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
Assessment:

The technology used in the Terumo ES-R800ST, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Japanese Society of HypertensionSelf-measurement (2016-2019)Possibly the intended device, listed as ES-R800 with an incomplete internal report

Device Family:Terumo ES-R800STJ, Terumo ES-R800SZJ (J JHS Implied Equivalence)
Validation Publications

血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.

JIS T 1115:2005 General population

JIS T 1115:2005 General population

There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800ST may be the device intended but caution is advised.

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.

Terumo ES-R800SZ

血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.

JIS T 1115:2005 General population

JIS T 1115:2005 General population

There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800SZ may be the device intended but caution is advised.