HealthAssure HL858JA

Device Model:HL858JA
Manufacturer:

Brand: Maestro Innovations Corporation (Health Assure), 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 235, TAIWAN PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the HealthAssure HL858JA, to measure blood pressure, has been declared as being equivalent to that used in a 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.

It is recommended by the BIHS on the basis of a manufacturer declaration of equivalence.