Wellvii VitalDetect
Device Name:
VitalDetect
Manufacturer:
Brand: Arc Devices Ltd., ℅ Ion Equity Limited, 15 Pembroke Street Lower, Dublin D02 DD35, IRELAND.
Distributer: Wellvii Europe, Windmolen 22, 7609 NM Almelo, NETHERLANDS.
Other: Wellvii Inc., Suite 626, 3801 PGA Blvd., Palm Beach Gardens, FL 33418, UNITED STATES.
Measuring functions:
Blood pressure, SpO2
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
BP & SpO2: Finger
Measurement Occurrence:
BP & SpO2: Single measurements only
Availability:
Available Currently
Device Specifications:
Description:
The Wellvii VitalDetect is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements and oxygen saturation measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Wellvii VitalDetect, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. There appears to be no peer-reviewed clinical validation information available on the technology used in the Wellvii VitalDetect to measure peripheral oxygen saturation.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
Validation Publications:
Li LY, Chen JF, Bing S, Liu K, Cheng R, Wan Y. Validation of the Wellvii VitalDetect blood pressure monitor in general population according to the International Standardization Organization 81060-2:2018. Blood Press Monit. 2024 Apr 1;29(2):93-98. Epub: 2023 Nov 15. doi: 10.1097/MBP.0000000000000683. PMID: 37997441.
81060-2:2019 - Pass General population