FDA-Device2022-08-03Class II

etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

Touch US Llc
Hazard

Device was marketed without FDA 510(k) clearance or a PMA.

Sold states
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Affected count
149
Manufactured in
94 Lilac Ln, Paramus, NJ, United States
Products
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2022

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