AOJ AOJ-30B (Black)
Device Model:
AOJ-30B (Black)
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:
Available Currently
Description:
The AOJ AOJ-30B (Black) 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 AOJ AOJ-30B (Black), 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 Assessment | Recommendation | Basis | |
| 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:
AOJ AOJ-30AF, AOJ AOJ-30B (Black)F, AOJ AOJ-30B (White)F, AOJ AOJ-30C (Black)F, AOJ AOJ-30C (White)F, AOJ AOJ-30DF, AOJ AOJ-30EF, AOJ AOJ-30FF, AOJ AOJ-30GF, AOJ AOJ-33AF, AOJ AOJ-33BF, Jumper JPD-HA120F, Jumper JPD-HA121F, OxiPro BP2Z, PangaO PG-800B22F, PangaO PG-800B26F, PangaO PG-800B31F, PangaO PG-800B32F, PangaO PG-800B35F, PangaO PG-800B36F
Legend: F FDA 510(k), Z Almost Certain
Legend: F FDA 510(k), 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.
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