Medical device recalls Moderate risk

LED Technologies, LLC recalls reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Dev…

Recall date
March 30, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1581-2016
FDA classification
Class II
Brand / firm
LED Technologies, LLC
Sold / distributed
Distributed to 1 consignee located in the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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