Compliance
Last updated: July 22, 2026
Please read this disclaimer carefully. It explains the regulatory status of the systems PRP Direct distributes and the limits of the information on prpdirectusa.com.
PRP Direct distributes 510(k)-cleared autologous blood-processing devices and their single-use kits, manufactured by Emcyte and others. These are point-of-care systems that concentrate a patient's own blood or tissue components at the chair. We are a distributor of the equipment and disposables. We do not perform procedures, prepare biologics for patients, or provide clinical services.
The systems we distribute are cleared by the FDA through the 510(k) process as blood-processing devices. That clearance applies to the device that processes blood or tissue. It is not an FDA approval or clearance of any prepared PRP, bone marrow concentrate, adipose preparation, A2M concentrate, or other biologic output to treat or improve any condition. Any preparation made with these devices is an autologous, point-of-care output, and its clinical use is a matter of the treating clinician's judgment and applicable law, not of the device's clearance.
Yields, purity figures, cell counts, timing, and other performance numbers shown on the site are manufacturer-reported device specifications. They describe what the device is designed to produce under the manufacturer's testing. They are not claims of the clinical efficacy of any prepared biologic, and they should not be read as a promise of any patient result. Vendor-authored data is presented as manufacturer-reported, not as independent findings.
Nothing on this site is medical, clinical, or professional advice, and nothing on it is a claim that any product or preparation treats or improves any condition. Content is provided for general informational and product-evaluation purposes for licensed medical professionals. It is not directed to patients and is not intended to guide the diagnosis or treatment of any individual.
Clinicians are solely responsible for all clinical decisions, including patient selection, indications, technique, and outcomes. Each device must be used in accordance with its own instructions for use (IFU) and applicable federal, state, and professional requirements. It is the clinician's responsibility to read, understand, and follow the IFU for every device and kit, and to comply with all laws governing the practice of medicine and the use of autologous biologics.
SuperShot is positioned as an add-on autologous blood-derivative in the same regulatory class as standard PRP. This is same-class positioning, not an FDA clearance or approval of SuperShot as a therapy. As with all products described here, no clinical efficacy or treatment claim is made.
Emcyte, PurePRP, PureBMC, and other product and brand names are trademarks of their respective owners. PRP Direct is an authorized distributor and references these marks only to identify the products it distributes.
We may update this disclaimer from time to time. When we do, we will revise the "Last updated" date above and post the current version on this page. The current version is always at this URL.
Questions about this disclaimer or the regulatory status of a system can be directed to:
PRP Direct
Email: info@newgenbiologics.com
Phone: (216) 202-4520