FDA WARNING_LETTER - Soulaire Corporation - December 07, 2023

The FDA issued a Warning Letter to Soulaire Corporation for marketing its External Counterpulsation (ECP) System Model: Soulaire without proper marketing clearance or approval for its expanded uses. The device, cleared under K202108 for chronic stable angina and general vasodilation/blood flow improvement under healthcare professional oversight, is being marketed for unapproved uses such as "growth of new arteries," "reduction or elimination of blood pressure medicine," "helps reduce symptoms of COVID-19," "excretes stem cells to repair organ dysfunction," "regeneration of pancreatic tissue," and "hair growth."

These expanded claims, found on the firm's website, constitute major changes to the device's intended use, for which Soulaire Corporation lacks evidence of safety or efficacy and has not obtained new premarket notification (510(k)) or premarket approval (PMA). The device is deemed adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) due to these unapproved changes and failure to notify the FDA. Furthermore, the website offers the device for sale to "business, . . . home or sports team," suggesting use without physician order or healthcare professional oversight, contrary to its cleared "Rx Only" status.

The FDA classifies ECP devices for uses beyond chronic stable