Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Tiller Mind Body, Inc. San Antonio, TX (2/25). Inspected 6/23-26/14. Unapproved device, adulterated, misbranded: The Libbe System was cleared under K941279 for colon cleansing when medically indicated, such as before radiological or endoscopic examinations. A device classified under 21 CFR 876.5220 (colonic irrigation system) is regulated as a Class 2 device when the device is intended for colon cleansing when medically indicated, but the firm’s promotion of the device shows it is intended for general well being and other non-medically indicated uses, which would constitute a major change or modification to its intended use, for which the firm lacks clearance or approval. For example, the firm claims that the device “improves the hydration status of the client/patient…and cleanses tissues at the cellular level and removes toxins …”, etc. (Libbe System); FDCA 501(f)(1)(B), 502(o), 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438222.htm

Zizion Group LLC Boca Raton FL (3/12). Reviewed the firm’s Web site http://yesprpkit.com. Uncleared or approved device, adulterated: The Web site describes the Yes PRP Kit as a kit for extracting blood from a patient, and preparing from that blood platelet rich plasma (PRP) for re-administration as a treatment for a number of conditions. The device has an intended use similar to the intended use of previously cleared PRP devices under 510(k) premarket notification, yet it does not have an approved PMA, IDE or a cleared 510(k). FDA also notes that the firm includes the FDA logo on its description of the product (linked to the phrase “in progress” in very small letters), which misleads the reader into concluding that the product is legally marketed in the U.S., etc. (Yes PRP Kit); FDCA 501(f)(1)(B), 515(a), 520(g), 510(k)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm