FDA WARNING_LETTER - Life Recovery Systems HD, LLC

The FDA issued a Warning Letter to Life Recovery Systems HD, LLC for marketing the ThermoSuit Systems without proper marketing clearance or approval. The ThermoSuit System was cleared under K061023 for temperature reduction in hyperthermic patients and temperature monitoring, for patients 58"-75" in height and less than 26" in width.

The FDA's Office of Compliance reviewed the firm's website, http://www.life-recovery.com, which promoted the ThermoSuit System for new intended uses not covered by its clearance. These new uses include preventing permanent tissue and neurological damage, increasing survival rates in cardiac arrest patients, and limiting brain and tissue damage after cardiac arrest. Examples of these claims were found on the website, including links to articles, journal excerpts, and videos.

These promotional claims cause the ThermoSuit to be adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). The device is also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the device for these new uses, as required by section 510(k).

Life Recovery Systems HD, LLC is required to immediately cease dissemination of similar promotional materials. The firm must submit a written response within 15 working days, detailing their compliance