BEUDAMED
    FDA Enforcement Class II Completed

    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

    Recall: Z-0348-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0348-2020
    Event ID
    84117
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Basic Reset Inc.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2019
    Initiation Date
    October 18, 2019
    Classification Date
    November 8, 2019
    Address
    260 W Main St Ste 103, N/A, Hendersonville, TN, 37075-7316, United States

    Description

    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

    Reason

    FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.

    Code Info

    All product distributed between November 7, 2017 to September 4, 2019

    Distribution

    US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates

    Quantity

    1257 units