Aktiia Init I1
Device Name:
Init I1
Manufacturer:
OBL: Aktiia SA, Rue de la Maladière 71C, 2002 Neuchâtel, SWITZERLAND.
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 ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Description:
The Aktiia Init I1 is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Aktiia Init I1, 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; older protocol |
Validation Publications:
Alexandre J, Tan K, Almeida TP, Sola J, Alpert BS, Shah J. Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. Blood Press Monit. 2023 Apr 1;28(2):109-112. Epub: 2023 Feb 17. doi: 10.1097/MBP.0000000000000639. PMID: 36795403. Available from: PMC9981319.
81060-2:2013 - Pass General population
This validation was carried out by the device developers; it is not independent.