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U.S. Department of Health and Human Services

Class 2 Device Recall reVive Light Therapy Pain Relief Device

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 Class 2 Device Recall reVive Light Therapy Pain Relief Devicesee related information
Date Initiated by FirmMarch 30, 2016
Date PostedApril 28, 2016
Recall Status1 Terminated 3 on November 30, 2016
Recall NumberZ-1581-2016
Recall Event ID 73779
510(K)NumberK081570 
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
ProductreVive 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.
Code Information Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052
Recalling Firm/
Manufacturer		 LED Technologies, LLC
6000 Greenwood Plaza Blvd
Ste 110
Greenwood Village CO 80111-4816
For Additional Information Contact
303-646-0543
Manufacturer Reason
for Recall		Incorrect Power Supply in the package, rendering the device inoperable.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomers were notified on March 30, 2016 via telephone call. LED Technologies, Inc. provided the consignee with a letter to distribute to customers who purchased the reVive Light Therapy Pain Relief device, and included instructions to receive a replacement of the correct power supply.
Quantity in Commerce32 units
DistributionDistributed to 1 consignee located in the United States.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ILY
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