Rossmax Accumed CH91
Description: The Rossmax Accumed CH91 is a non-clinically-validated semi-automatic surface-placed blood pressure monitor. Measurements are taken from the upper arm and 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 Accumed CH91 to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device has not shown to have been clinically validated. | ||
Device Family:Rossmax Accumed CH91Z, Rossmax CH91 (V1)Z, Rossmax CH91 (V2)Z (Z Almost Certain)
