Dr. PRP USA Receives FDA 510K Clearance for Its PRP Kits

STAFFORD, Tex. (June 21, 2023) – Dr. PRP USA LLC is proud to announce it has received 510K approval from the Food & Drug Administration (FDA) for its PRP kits . Now that the 510K clearance is final, Dr. PRP can continue to expand its market providing PRP kits to medical providers.

“We are so proud that we have received the necessary clearances to effectively market our best-in-class PRP kits,” said George Bretz, Managing Partner of Dr. PRP USA.

The 510K approval or clearance is so named because it comes from Section 510(k) of the Food, Drug and Cosmetic Act requiring device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as a Premarket Notification - also called a PMN – a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective.

Bretz, a cardiovascular perfusionist and a leader in the U.S. healthcare industry for over 36 years with a passion for introducing innovative techniques, says he looks forward to the widespread availability of PRP technology, opening new markets and bringing PRP to people everywhere.

Platelet rich plasma (PRP) therapy involves removing, processing, and re-introducing an individual’s own cells to treat or prevent a medical condition. The process involves collecting a small amount of blood and spinning it in a centrifuge machine to separate the platelets from the red blood cells. PRP treatment has been in increasingly wide use for the past decade but is now being brought to the center of the U.S. medical market and is now actively being used in various medical fields.

PRP treatment is especially helpful in supporting wound healing after surgery, severe injury, or trauma. Originally developed in the 1970s, PRP was first used during open heart surgery in the late 1980s as an aid in healing. Thereafter, post-surgical PRP injections began being used in procedures where tissues have notoriously long recovery times. But PRP has even wider applications.

In the past decade, the technique has been used to address aesthetic conditions like male pattern baldness, and its clinical applications have ranged from staving off knee replacements to treating carpal tunnel syndrome. PRP’s clinical use to promote the body’s own natural healing capabilities holds incredible medical promise.

Because the treatments use a patient’s own tissues, PRP injections are safe and can be administered alone or used in conjunction with other procedures.

For medical suppliers or medical providers interested in learning more about the Dr. PRP USA line of PRP kits, you may reach the company directly at 844-377-7787. Additional information can also be found on the company's website: https://www.drprpusa.com.

About Dr. PRP USA LLC

Dr. PRP USA LLC offers the most advanced and affordable PRP Preparation System on the market. Dr. PRP USA LLC is a privately held American company committed to introducing advanced, sophisticated, more effective, and naturally healthier medical technologies like PRP therapy into the American healthcare system. Dr. PRP’s dedicated research and development has paved the way for new products like the Dr. PRP Regenerative Therapy Kit, which is a simple and highly functional aid for separating platelets used in regenerative therapy. Dr. PRP USA’s product line for PRP collection has been registered by the FDA for regenerative use by healthcare providers in labs, treatment facilities, and med spas, and its FDA 510K has received full clearance.