FDA WARNING_LETTER - Pressure Tech Inc

The FDA issued a Warning Letter to Pressure-Tech, Inc. after discovering the firm is marketing hyperbaric chamber accessories, specifically Pure Air 5 and Pure Air 5T Air Compressors, in the U.S. without the required marketing clearance or approval. These products, identified as accessories to Class 2 hyperbaric chambers (21 CFR 868.5470), necessitate a 510(k) application for clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act. The firm's failure to obtain this clearance renders their products adulterated under section 501(f)(1)(B) of the Act, due to the absence of an approved premarket approval (PMA) or investigational device exemption. Additionally, the products are misbranded under section 502(o) for failing to notify the FDA of their intent to commercially distribute, as required by section 510(k). Pressure-Tech, Inc. must promptly correct these violations and provide a written response within fifteen business days detailing corrective actions, preventive measures, and a timetable for completion. Failure to comply may result in severe regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts.