Spinal decompression device now sold in the U.S.

Source：Integrity Life Sciences Release Date：2012-07-20 426

Medical Equipment

Integrity Life Sciences receives FDA 510(k) for its Integrity Spinal Care System medical device

TAMPA, FL -- Integrity Life Sciences have announced that the U.S. Food and Drug Administration (FDA) issued a 510(k) that permits Integrity to market their non-surgical spinal decompression therapy systems in the U.S. The Integrity Spinal Care System (ISCS 2.0) is the newest device in the U.S. to achieve this regulatory decision for similarly marketed devices.

Prior to formal submission to the FDA, Integrity submitted its application to TüV Rheinland of North America as the third party reviewer.

Integrity Life Sciences delivers an advanced solution to address chronic low back and neck pain, one of the most costly systemic ailments in the world. 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. In non-surgical spinal decompression, 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, relieving pressure on nerves and intervertebral discs. This causes pressure to drop within the disc, which facilitates movement of fluid, carrying nutrients and oxygen inside the disc. The reduction in pressure can also help draw in herniated disc fluids, reducing the size of the herniation.New Arrivals