BEUDAMED
    FDA Enforcement Class II Terminated

    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    Recall: Z-1541-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1541-2015
    Event ID
    70737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Therasage, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    December 23, 2014
    Classification Date
    April 28, 2015
    Termination Date
    August 6, 2015
    Address
    21000 Boca Rio Rd Ste A21c, Boca Raton, FL, 33433-1504, United States

    Description

    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .

    Reason

    Product distributed without 510(k) approval

    Code Info

    PS2002

    Distribution

    Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.

    Quantity

    8 devices