PangaO PG-800B26
Device Model:
PG-800B26
Manufacturer:
Shenzhen Pango Electronic Co. Ltd., 1st Industrial Zone, 25 Fenghuang Lu, Xikeng, Henggang, Longgang District, Shenzhen, 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 PangaO PG-800B26 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the PangaO PG-800B26, to measure blood pressure, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | ★★ Recommendation | Recent clinical validation; older protocol; multiple clinical validations |
BP | BIHS (UK and IRL) | Self-measurement | Published evidence |
BP | Stride BP | Self-measurement for adults (Preferred) | Published evidence |
BP | FDA (US) | 510(k) | 510(k) K170151 |
BP | MDR Criteria | Self-measurement | Published evidence |
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:
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