Device Model:
MA-801F
Manufacturer:
OBL: Alliance Unichem IP Ltd. (Alvita), 2 The Heights, Brooklands, Weybridge, Surrey KT13 0NY, UNITED KINGDOM.
OEM: Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, TAIWAN ROC.
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
Device Manual:
Description:
The Alvita MA-801F 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 upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Alvita MA-801F, 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP |
BIHS (UK and IRL) |
Self-measurement (Previous) |
Manufacturer declaration of equivalence to the Rossmax CF175 |
| BP |
ESH (Europe) |
Self-measurement |
The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria. |
Device Family:
Alvita MA-801FB,
Alvita CG-155FB,
Aspen C5B,
Aspen CF155FB,
Lloyds CardioZ,
Rossmax AC1000f (V1)B,
Rossmax CF155fB,
Rossmax CF175f (V1)B,P,
Rossmax CH155f (V2)B,
Rossmax X1 (V1)B,P,
Rossmax X3 (V1)B,P,
Rossmax X5 (V1)B,
Rossmax X9B,P,
Rossmax Accumed Carrdio C5B,
Rossmax X5 (V2)P,
Rossmax CH155f (V1)B,
Rossmax X9 BTZ,
Rossmax Z1B,P,
Rossmax Z5B,PLegend:
B BIHS Derivative,
P Stride Equivalence,
Z Almost Certain
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 CF175f (V1)
Zhang L, Kang YY, Zeng WF, Li Y, Wang JG. Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Apr;20(2):104-7. doi: 10.1097/MBP.0000000000000089. PMID: 25350783.
ESH-IP:2010 - Pass General population
