Recall Z-1581-2016— LED Technologies, LLC

Name: FDA recall Z-1581-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-30

Class II · Terminated

Class II FDA medical device recall by LED Technologies, LLC, initiated 2016-03-30, terminated 2016-11-30. It names one FDA 510(k) clearance: K081570. Product: 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..

Recalling firm: LED Technologies, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-03-30
Terminated: 2016-11-30
Firm location: Greenwood Village, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K081570 — DPL THERAPY SYSTEMLed Technologies, LLC·cleared 2008-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.