Formegga ML-8021

Device Model:

ML-8021

Manufacturer:

ZheJiang Formegga Health Technology Co. Ltd., Changhong East-street, Economic & Development Zone, Deqing County, Huzhou, 313200 Zhejiang, CHINA.

Measuring functions:

Blood Pressure and PR

Primary Client Use:

Intended for both professional use and self-measurement

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Formegga ML-8021 is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for both professional use and self-measurement.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Formegga ML-8021 to measure blood pressure.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been clinically validated.