Hingmed DBP-01HP

Description:

The Hingmed DBP-01HP is a waiting-room 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 use as a public facility.

Assessment:

The technology used in the Hingmed DBP-01HP, to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant 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.

Device Family:

A&D UA-1200CNBLE - 1200 UltraConnectZ, A&D UA-1200BLEZ, Hingmed DBP-01HPF, Hingmed DBP-01PF
Legend: F FDA 510(k), Z Almost Certain

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.

A&D UA-1200BLE

Kario K, Saito K, Sato K, Hamasaki H, Suwa H, Okura A, Hoshide S. Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2: 2013 standard. Blood Press Monit. 2018 Dec;23(6):312-314. Epub: 2018 Sep 7. doi: 10.1097/MBP.0000000000000347. PMID: 30199378.

81060-2:2013 - Pass General population

Hingmed DBP-01P

Fania C, Giletto A, Zanello V, Palatini P. Validation of the Hingmed DBP-01P clinical automatic blood pressure monitor provided with wide-range cuff, evaluated in a general population according to the ISO 81060-2:2018 protocol. Blood Press Monit. 2023 Apr 1;28(2):116-120. Epub: 2023 Feb 17. doi: 10.1097/MBP.0000000000000638. PMID: 36916471.

81060-2:2019 - Pass General population