FDA WARNING_LETTER - Oxyhealth, LLC

The FDA issued a Warning Letter to OxyHealth, LLC for marketing hyperbaric chambers without marketing clearance or approval. The FDA's Office of Compliance reviewed OxyHealth's website and found the firm markets Solace 210, Respiro 270, Vitaeris 320, and Quamvis 320 hyperbaric chambers. These are Class 2 devices (21 CFR 868.5470) requiring 510(k) clearance.

The products are adulterated under section 501(f)(1)(B) of the Act because OxyHealth lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failing to notify the FDA of intent to introduce the products into commercial distribution, as required by section 510(k).

OxyHealth must take prompt action to correct these violations. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The firm must respond in writing within fifteen business days, detailing specific corrective steps, prevention plans, and a timetable for implementation if corrections will take longer. The response should be comprehensive and address all violations.