Finicare FC-BP127
Device Model:
FC-BP127
Manufacturer:
Shenzhen Finicare Co. Ltd., No. 201, No. 50, The Third Industrial Zone, Houting Community, Shajing Street, Baoan District, Shenzhen, Guangdong, CHINA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Finicare FC-BP127 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 upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Finicare FC-BP127, 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. |
Device Family:
Finicare FC-BP100F, Finicare FC-BP101F, Finicare FC-BP102F, Finicare FC-BP103F, Finicare FC-BP106F, Finicare FC-BP110F, Finicare FC-BP111 (V1)F, Finicare FC-BP111 (V2)F, Finicare FC-BP112F, Finicare FC-BP113F, Finicare FC-BP116F, Finicare FC-BP120F, Finicare FC-BP121 (V1)F, Finicare FC-BP121 (V2)F, Finicare FC-BP123F, Finicare FC-BP126F, Finicare FC-BP127F, Finicare FC-BP130F, Finicare FC-BP131F
Legend: F FDA 510(k)
Legend: F FDA 510(k)