Device Model:
UA-651BLE-HH
Manufacturer:
Brand: Hello Heart Inc., Suite 220, 545 Middlefield Rd, Menlo Park, CA 94025, UNITED STATES.
OEM: A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Hello Heart UA-651BLE-HH 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 Hello Heart UA-651BLE-HH 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:
A&D UA-611B,J,
A&D UA-651B,J,P,
A&D UA-651BLEJ,
A&D UA-767SB,
A&D UA-767S-WB,
A&D UA-651MR (UA-651A-JC11)J,
A&D UA-654MR (UA-654B-JC61)J,P,
A&D UA-651BLE Plus (UA-651LB-JC11)J,
A&D UA-654 Plus (UA-654B-JCB1)J,
Hello Heart UA-651BLE-HHZLegend:
B BIHS Derivative,
J JHS Implied Equivalence,
P Stride Equivalence,
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.
A&D UA-651
Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):50-3. doi: 10.1097/MBP.0000000000000020. PMID: 24346435.
ESH-IP:2010 - Pass General population
Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Jun;20(3):164-7. Epub: 2014 Dec 22. doi: 10.1097/MBP.0000000000000100. PMID: 25536400.
ESH-IP:2010 - Pass General population
