FDA clears text

FDA Clears SoftWave’s Shockwave Treatment

May 20, 2021

SoftWave Tissue Regeneration Technologies has received 510(k) clearance from the FDA for OrthGold 100, a device for temporarily increasing blood circulation, relieving minor aches and pains, and activating connective tissue.

The extracorporeal shockwave device is used by physicians and healthcare professionals to provide relief from tendonitis, bursitis, arthritis and other common conditions.

The technology delivers a shockwave from outside the body that promotes a physical and biological response to improve healing, positively influencing the activity of immune cells. It also intervenes directly in signal transmission of pain.

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