BEUDAMED
    FDA Enforcement Class II Terminated

    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

    Recall: Z-1581-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1581-2016
    Event ID
    73779
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LED Technologies, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 30, 2016
    Classification Date
    April 27, 2016
    Termination Date
    November 30, 2016
    Address
    6000 Greenwood Plaza Blvd, Ste 110, Greenwood Village, CO, 80111-4816, United States

    Description

    reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

    Reason

    Incorrect Power Supply in the package, rendering the device inoperable.

    Code Info

    Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052

    Distribution

    Distributed to 1 consignee located in the United States.

    Quantity

    32 units