Device Model:
BP1
Manufacturer:
OBL: AlcoSense Laboratories (OxiPro Medical Devices), Part of Now Group UK Ltd., Unit 3, Maidenhead Enterprise Centre, Cordwallis Street, Maidenhead SL6 7BE, UNITED KINGDOM.
OEM: 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
Availability:
Available Currently
Description:
The OxiPro BP2 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:
There appears to be no peer-reviewed clinical validation information available on the technology used in the OxiPro BP2 to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol 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. |
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-800B36FLegend:
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
