Panasonic EW-BU36
Device Model:
EW-BU36
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:
Discontinued but still available
Availability according to Countries or Regions:
Japan
Description:
The Panasonic EW-BU36 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Panasonic EW-BU36, 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 | Japanese Society of Hypertension | Self-measurement (Latest: 2017, 2019-2022) | Implied equivalence to the Panasonic EW-BU15 |
Device Family:
Panasonic EW-BU15J, Panasonic EW-BU16J, Panasonic EW-BU36J, Panasonic EW-BU56J
Legend: J JHS Implied Equivalence
Legend: 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)