Pempa BP80 - Medaval

Description:

The Pempa BP80 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 Pempa BP80, 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	Equivalence to the Combei BP118A claim without published evidence

Device Family:

Combei BP118AP, Pempa BP100P, Pempa BP80P, Prolife PA5-Comfort (BP136A)P
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.

Combei BP118A

Tasić N, Topouchian J, Tasic D, Kovacevic Z, Filipovic M, Asmar R. Accuracy of the COMBEI BP118A Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Vasc Health Risk Manag. 2022 Mar 12;18:123-129. doi: 10.2147/VHRM.S353715. PMID: 35309162. Available from: PMC8926011.

81060-2:2019 - Pass General population