Omron HCR-7602T
Device Model:
HCR-7602T
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
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 Omron HCR-7602T is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Omron HCR-7602T to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but 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 | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
Omron HEM-7320FJ,Y, Omron HEM-7324CJ, Omron HEM-8731J, Omron HEM-7281TJ, Omron HEM-7313J, Omron HEM-7325TJ, Omron HEM-7310J, Omron HCR-7201J, Omron HCR-7409J, Omron HCR-7501TJ, Omron HCR-7106J, Omron HCR-7402Z, Omron HCR-7502TZ, Omron HCR-7602TZ, Omron HEM-7320 (HEM-7320-AP)Y, Omron HCR-7204TJ, Omron HCR-7206T2J, Omron HCR-7407J, Omron HCR-7308T2J, Omron HCR-7524TJ, Omron HCR-7628TJ
Legend: J JHS Implied Equivalence, Y Internal declaration, Z Almost Certain
Legend: J JHS Implied Equivalence, Y Internal declaration, Z Almost Certain
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Omron HEM-7320F
Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.
ESH-IP:2010 - Pass General population