Home /  Panasonic EW-BU16

Panasonic EW-BU16

Device Model:EW-BU16
Manufacturer:Panasonic, One Panasonic Way, 1H-1 Secaucus, NJ 07094, UNITED STATES.
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 Panasonic EW-BU16 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 Panasonic EW-BU16, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2017, 2019-2020)Implied equivalence to the Panasonic EW-BU15

Device Family:Panasonic EW-BU15J, Panasonic EW-BU16J, Panasonic EW-BU36J, Panasonic EW-BU56J (J JHS Implied 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.

Panasonic EW-BU15

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger 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:2007 - Pass General population (Note: 2011)