AOJ AOJ-30A
Device Model:
AOJ-30A
Manufacturer:
Shenzhen AOJ Medical Technology Co. Ltd., 4F + 3F Area A, Building A, Jingfa Industrial Park, Xiawei Yuan, Xixiang Street, Bao'an District, Shenzhen 518101, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Device Accessibility:
Large text plus voiced instructions and results
Availability:
Discontinued but still available
Description:
The AOJ AOJ-30A 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the AOJ AOJ-30A, to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP FDA (US) 510(k) 510(k) K191180
Device Family:
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.

PangaO PG-800B26

Chen L, Li J, Wen J, Guo C, Zhang J, Yu Z. Validation of the Pangao PG-800B26 upper arm blood pressure monitor in the general population according to the European Society of Hypertension and the British Hypertension Society protocols. Blood Press Monit. 2018 Feb;23(1):41-4. Epub: 2017 Sep 11. doi: 10.1097/MBP.0000000000000289. PMID: 28902676.

ESH-IP:2010 - Pass General population

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

81060-2:2013 - Pass General population