Visgeneer eBwell (eB-W01)

Device Name:

eBwell

Device Model:

eB-W01

Manufacturer:

Visgeneer Inc., No. 335 Sec. 6, Zhonghua Rd., Xiangshan Dist., Hsinchu City 30094, TAIWAN ROC.

Measuring functions:

Blood glucose, β-Ketones

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Visgeneer eBwell (eB-W01) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are taken from the finger. 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 Visgeneer eBwell (eB-W01) to measure blood glucose.

Recommendations:

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