Dretec BM-201
Device Model:
BM-201
Manufacturer:
Dretec Co. Ltd., 2-3-9 Ryutsu-Danchi, Koshigaya-shi, Saitama 343-0824, JAPAN.
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
Availability according to Countries or Regions:
Japan
Device Manual:
Description:
The Dretec BM-201 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:
While the technology used in the Dretec BM-201, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BP | Japanese Society of Hypertension | Self-measurement (Previous: 2019) | Unpublished validation |