AOJ AOJ-35C
Device Model:
AOJ-35C
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 and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Device Accessibility:
Voiced instructions and results
Availability:
Available Currently
Description:
The AOJ AOJ-35C is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the AOJ AOJ-35C, 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 | Not recommended | This device has not been shown to have been clinically validated. |
| BP | FDA (US) | 510(k) | 510(k) K213503 |
Device Family:
AGE BW-601F, AGE BW-602F, AGE BW-603F, AGE BW-606F, AOJ AOJ-35BF, AOJ AOJ-35CF, AOJ AOJ-35D (Black)F, AOJ AOJ-35D (White)F, AOJ AOJ-35EF
Legend: F FDA 510(k)
Legend: F FDA 510(k)