FDA WARNING_LETTER - Pulse Health Llc - June 08, 2012

On September 28, 2012, the FDA issued a Warning Letter to Pulse Health, LLC following an inspection from May 29 to June 8, 2012, at their Portland, Oregon facility. The inspection determined that Pulse Health manufactures the REVELAR device, which is intended for diagnosing disease or affecting body functions, classifying it as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The REVELAR device was found to be adulterated under section 501(f)(1)(B) of the Act because Pulse Health lacked an approved premarket approval (PMA) application or an approved investigational device exemption. It was also deemed misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k). Specific claims from the firm's Support Guide and website, such as "Revelar can accurately assess free radical damage and improve the health of your patients" and linking free radical damage to various serious conditions, were cited as evidence of the device's intended use.

Additionally, Pulse Health failed to fulfill annual establishment registration and device listing requirements under section 510 of the Act, leading to further misbranding under section 502(o). The FDA acknowledged the firm's June