Rossmax CH91 (V1)
Device Model:
CH91 (Note: 1 of 2)
Manufacturer:
Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, TAIWAN ROC.
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:
Discontinued but still available
Device Manual:
Description:
The Rossmax CH91 (V1) is a surface-placed semi-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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Rossmax CH91 (V1) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and 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 | Not recommended | This device has not been shown to have been clinically validated. |
Device Family: