H&L HL158AU-D
Device Model:
HL158AU-D
Manufacturer:
Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The H&L HL158AU-D 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 wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the H&L HL158AU-D, 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 H&L HL168JD claim without published evidence |
Device Family:
Citizen CH-617B, Citizen CH-618B, H&L HL168JDB, H&L HL168ZAB, H&L HL168KBB, H&L HL158AU-DP, Maestro HL158JAB, Maestro HL158SAB, Health Assure HL158JAB, Walgreens WGNBPW-710B, Walgreens WGNBPW-720B
Legend: B BIHS Derivative, P Stride Equivalence
Legend: B BIHS Derivative, 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.
H&L HL168JD
Sheng CS, Huang QF, Wang J, Zhang Y, Li Y, Wang JG. Validation of the Health & Life HL168JD wrist blood pressure monitor for home blood pressure monitoring according to the International Protocol. Blood Press Monit. 2009 Jun;14(3):125-7. doi: 10.1097/MBP.0b013e32832ce106. PMID: 19454865.
ESH-IP:2002 - Pass General population