HoMedics BPA-2000-EU

Device Model:BPA-2000-EU
Manufacturer:

OBL: HoMedics Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, UNITED STATES.

OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.

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 HoMedics BPA-2000-EU, 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
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria.
 
Consumer BodyVersionQuartileComment
Which? (UK)2019A 

Device Family:Braun ExactFit 3 (BP-6000)B,D, Braun ExactFit 5 (BP-6200)B,D, Braun ExactFit 3 (BP-6100)B,D, HoMedics BPA-3000-EUB, Transtek TMB-986B,D (B BIHS Derivative, D DET Equivalence)