Brand: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Distributer: OMRON Healthcare Inc., 1925 West Field Court, Lake Forest, Illinois 60045, UNITED STATES.
Other: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | AMA VDL (US) | Self-measurement | Implied equivalence to the Omron HEM-6181 plus 510(k) K182127 |
| BP | FDA (US) | 510(k) | 510(k) K182127 |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Consumer Reports (US) | 2021-2025 | Very Good |
Legend: L AHA VDL Implied Equivalence, P Stride Equivalence, F FDA 510(k), Y Internal declaration
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-6181
Saito K, Hishiki Y, Takahashi H. Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. PMID: 30881007. Available from: PMC6410757. eCollection 2019. Erratum in: Vasc Health Risk Manag. 2019 May 17;15:137.
81060-2:2013 - Pass General population
ESH-IP:2010 - Pass General population
The studies use the same data and are, therefore, not independent.