Prolife PA5-Comfort-AF (BP136A)

Device Name:

PA5-Comfort-AF

Device Model:

BP136A (Note: 2 of 3)

Manufacturer:

OBL: Montex Swiss AG (Prolife), Tramstrasse 16, CH-9442 Berneck, SWITZERLAND.

OEM: Combei Technology Co. Ltd., Floor 3, Bldg. B, Jinxiongda Technology Park, 105 Huanguan South Road, Dahe Community, Guanlan Street, Bao'an, Shenzhen, Guangdong 518110, CHINA.

Measuring functions:

Blood Pressure, PR and Atrial fibrillation

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Prolife PA5-Comfort-AF (BP136A) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Prolife PA5-Comfort-AF (BP136A), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BP	Stride BP	Self-measurement for adults	Published evidence

Validation Publications:

Menti A, Ntousopoulos V, Lempidaki P, Bakalakou KR, Mariglis D, Komnianou A, Ntaskagianni E, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Prolife PA5 Comfort AF (BP 136A) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. Epub: 2026 Jan 26. doi: 10.1097/MBP.0000000000000793. PMID: 41589721.

81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population