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Nissei DS-500

Device Model:DS-500
Manufacturer:Nihon Seimitsu Sokki Co. Ltd. (Nissei), 2508-13 Nakago Shibukawa, Gunma 377-0293, 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
Description: The Nissei DS-500 is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The technology used in the Nissei DS-500, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
ESH (Europe)Self-measurement for adults and pregnancyPublished evidence

Device Family:Beurer BM 60D, Nissei DS-400D, Nissei DS-500D (D DET 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.

Beurer BM 60

Tholl U, L├╝ders S, Bramlage P, Dechend R, Eckert S, Mengden T, N├╝rnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2011)

Nissei DS-400

Duhig KE, De Greeff A, Van Der Westhuizen A, Baker E, Shennan AH. Validation of the Nissei DS-400 in a low-resource setting. Blood Press Monit. 2009 Jun;14(3):132-5. doi: 10.1097/MBP.0b013e32832ce136. PMID: 19433979.

ESH-IP:2002 - Pass Low resource setting

de Greeff A, Shennan AH. Clinical accuracy of a low cost portable blood pressure device in pregnancy and pre-eclampsia: the Nissei DS-400. Trop Doct. 2015 Jul;45(3):168-73. Epub: 2015 Apr 23. doi: 10.1177/0049475515581542. PMID: 25911652.

BHS:1993 - Pass (A/A) Pregnancy and pre-eclampsia (n=45)