BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1461-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1461-2022
    Event ID
    90523
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Touch US Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 3, 2022
    Initiation Date
    June 21, 2022
    Classification Date
    July 26, 2022
    Address
    94 Lilac Ln, Paramus, NJ, 07652-5291, United States

    Description

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

    Reason

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

    Code Info

    UDI-DI (GTIN): 00195893740581

    Distribution

    US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA

    Quantity

    149