H&L HL858DK - Medaval

Description:

The H&L HL858DK 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:

While the technology used in the H&L HL858DK, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol 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.
BP	BIHS (UK and IRL)	Self-measurement (Previous)	Manufacturer declaration of equivalence to the Health & Life HL888HA
BP	FDA (US)	510(k)	510(k) K180240

Device Family:

Cresta BPM610B, Cresta BPM701B, Medicare Lifesense A2 (MD638)B, H&L HL858BAB, H&L HL858GAB, H&L HL858HAB, H&L HL868ZAB, H&L HL868ZBB, H&L HL888HAB, H&L HL888HCB, H&L Airssential AI-H971B, H&L HL858DKB, Maestro HL858JAB, Maestro HL858SAB, Health Assure HL858JAB, Medisana BU 582 (51582)Y, Proton PHC-888EAB, Proton PHC-888UPB, Seagull S-888HAB, Walgreens WGNBPA-730B, Walgreens WGNBPA-740B, Walgreens WGNBPA-750B
Legend: B BIHS Derivative, Y Internal declaration

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.

H&L HL888HA

de Greeff A, Shennan AH. The Health and Life device (HL888HA): accuracy assessment in an adult population according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):107-11. PMID: 17353654.

BHS:1993 - Pass (A/A) General population

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:1999 - Pass General population (Note: 2003)