Omron RS2 (HEM-6121-E)
Assessment:
While the technology used in the Omron RS2 (HEM-6121-E), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Not recommended | This device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically. | ||
| BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence | ||
| DHL (DE) | General use | Manufacturer declaration of equivalence | ||
| Consumer Body | Version | Quartile | Comment | |
| Stiftung Warentest (DE) | Most recent: 2018 | B | ||
| Which? (UK) | 2019 | A | ||
Device Family:Omron RS1 (HEM-6120-D)D, Omron RS3 (HEM-6130-E)B,D (B BIHS Derivative, D DET Equivalence)
