Vitammy Next E1
Device Name:
Next E1
Manufacturer:
OBL: Novamed S.A. (Vitammy), ul. dr. Stefana Kopcińskiego 62D, 90-032 Łódź, POLAND.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Vitammy Next E1 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:
The technology used in the Vitammy Next E1, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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. |
| BP | Stride BP | Self-measurement for adults (Preferred) | Equivalence to the Jamr F1701T claim without published evidence |
Device Family:
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.
Jamr F1701T
Li J, Han LH, Feng R, Wu LH, Cai J, Zeng TY, Liu H, Zeng YW, Zhou L, Zhan ZQ. Validation of the JAMR F1701T (arm type) pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ISO 81060-2:2018 protocol. Blood Press Monit. 2023 Jun 1;28(3):163-166. Epub: 2023 Mar 7. doi: 10.1097/MBP.0000000000000643. PMID: 37016972. Available from: PMC10132453.
81060-2:2019 - Pass (n=90)