BEUDAMED
    FDA Enforcement Class II Terminated

    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

    Recall: Z-1808-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1808-2017
    Event ID
    76787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    2k Innovations Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    April 15, 2016
    Classification Date
    April 12, 2017
    Termination Date
    August 7, 2019
    Address
    110 Cumberland Park Dr Ste 205, N/A, Saint Augustine, FL, 32095-8901, United States

    Description

    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps

    Reason

    During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

    Code Info

    Item #GL-7V-FR

    Distribution

    Nationwide Distribution

    Quantity

    22,757 items in total