BEUDAMED
    FDA Enforcement Class II Terminated

    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.

    Recall: Z-2736-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2736-2018
    Event ID
    80483
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hudson Scientific LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 15, 2018
    Initiation Date
    July 2, 2018
    Classification Date
    August 8, 2018
    Termination Date
    January 13, 2020
    Address
    103 W Main St, N/A, Hudson, MI, 49247-1022, United States

    Description

    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.

    Reason

    The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.

    Code Info

    Device Lot/ Batch Numbers: 012016, 032016, 112016, 122016, 012017, 022017, 032017, 092017, 112017, 012018 Device Serial Numbers: 35,949 MAC Numbers ranging from 0F:72: D9:E9: F4:5A to FF: FF: AB:37: 7A:0C

    Distribution

    Nationwide distribution. Worldwide distribution.

    Quantity

    35,949 units