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Rossmax AW151

Device Model:AW151
Manufacturer:Sole: Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, 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:Discontinued but still available
Assessment:

While the technology used in the Rossmax AW151, 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.

Rossmax ME701

de Greeff A, Shennan AH. The Rossmax (ME 701 series) upper arm device: accuracy assessment in an adult population according to the International and the British Hypertension Society protocols. Blood Press Monit. 2008 Feb;13(1):43-8. doi: 10.1097/MBP.0b013e3282ca913f. PMID: 18199923.

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

SP10:1996 - Pass General population