Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT)
Device Name:
BP A3L Comfort
Device Model:
BP 3GX1-3A, A3L-IMT
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure, Arrhythmias
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Bulgaria, Belarus, Finland, France, Greece, Latvia and Ukraine
Device Manual:
Description:
The Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT) 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:
The technology used in the Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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 | Stride BP | Self-measurement for adults (Preferred) | Equivalence claim without published evidence |
Device Family:
Microlife BP A200 (BP 3MS1-4K)B, Microlife BP A200 Comfort (BP 3MS1-4A)B,P,F, Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT)P
Legend: B BIHS Derivative, P Stride Equivalence, F FDA 510(k)
Legend: B BIHS Derivative, P Stride Equivalence, F FDA 510(k)
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.
Microlife BP A200 Comfort (BP 3MS1-4A)
Bing S, Chen K, Hou H, Zhang W, Li L, Wei J, Shu C, Wan Y. Validation of the Microlife BP A200 Comfort and W2 Slim automated blood pressure monitors in a general adult population according to the European Society of Hypertension and the ANSI/AAMI/ISO 81060-2: 2013 protocols. Blood Press Monit. 2016 Apr;21(2):118-23. Epub: 2015 Dec. doi: 10.1097/MBP.0000000000000169. PMID: 26683381.
ESH-IP:2010 - Pass General population
81060-2:2013 - Pass General population