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Integrity Life Sciences Receives US FDA 510(k) Clearance for its Integrity Spinal Care System Medical Device
Date:7/9/2012

TAMPA, Fla., July 9, 2012 /PRNewswire-iReach/ -- Integrity Life Sciences announced today that on April 5th, 2011, the US Food and Drug Administration issued to Integrity Life Sciences a 510(k) that permits Integrity to legally market their recently developed medical device in the USA. Integrity is also the manufacturer and together with efforts of Third Party Reviewer, TUV Rheinland of North America, the Integrity Spinal Care System is the newest device in America to achieve this regulatory decision as it pertains to similarly marketed devices. The FDA 510(k) was issued from the US FDA's, Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation, Center for Devices and Radiological Health.

(Photo: http://photos.prnewswire.com/prnh/20120709/CG37266)

The theory behind non-surgical spinal decompression is a process whereby forces are applied to the spine in a manner that maximizes spinal elongation. Spinal elongation is maximized when paraspinal muscles, the muscles that guard the spine from injury, are relaxed. When paraspinal muscles relax, applied spinal decompressive forces spread apart the bony vertebra of the spine. This relieves pressure on nerves and intervertebral discs. Where this spinal elongation occurs, pressure drops within the disc which facilitates movement of fluid, carrying nutrients and oxygen inside the disc. Additionally, the reduction in pressure can help draw in herniated disc fluids, reducing the size of the herniation. Integrity Life Sciences delivers an advanced solution to address one of the most costly systemic ailments in the world, chronic low back and neck pain. The ISCS 2.0 and Lombare Systems are non-surgical spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine. 

The US FDA 510(k) # k103248 Intended Use reads as follows: "The Integr
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SOURCE Integrity Life Sciences
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