VivaChek Ino Sound (VGM09)

Device Name:

Ino Sound

Device Model:

VGM09

Manufacturer:

Distributer: VivaChek Laboratories Inc., Suite 200, 913 N Market Street, Wilmington, DE 19801, UNITED STATES.

Other: VivaChek Biotech (Hangzhou) Co. Ltd., Level 2, Block 2, 146 East Chaofeng Road, 311100 Hangzhou, CHINA.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Device Accessibility:

Voiced instructions and results

Availability:

Available Currently

Description:

The VivaChek Ino Sound (VGM09) 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 VivaChek Ino Sound (VGM09) to measure blood glucose.

Recommendations:

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