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Maestro HL158JA

Device Model:HL158JA
Manufacturer:

OBL: Maestro Innovations Corporation, 8F-7, 155 Jhongyang Road, Sindian District, New Taipei City, TAIWAN PRC.

OEM: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN PRC.

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
Assessment:

While the technology used in the Maestro HL158JA, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of 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