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.
FDA Recall Z-1581-2016 · Posted 2016-04-28
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Recalling FirmLED Technologies, LLC
Recall StatusTerminated
Product CodeILY
Date Initiated2016-03-30
Date Terminated2016-11-30
Product Quantity32 units
Reason for Recall
Incorrect Power Supply in the package, rendering the device inoperable.
Firm Action
Customers 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed to 1 consignee located in the United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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