FDA WARNING_LETTER - Hyperbaric Options

The FDA issued a Warning Letter to Hyperbaric Options, LLC, and its CEO, Gregory Harris, for marketing hyperbaric chamber accessories without required marketing clearance or approval. The FDA identified products like the CoolPressure Air Cooler and various oxygen concentrators on the firm's website as devices intended for use with Class 2 hyperbaric chambers (21 CFR 868.5470). As accessories to Class 2 devices, these products require 510(k) clearance. The letter states the products are adulterated under section 501(f)(1)(B) of the Act due to the absence of an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act because the firm failed to submit a 510(k) notification. Additionally, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2013, rendering all devices misbranded under sections 502(o), 510, and 510(j) of the Act. Hyperbaric Options, LLC must take prompt corrective action and respond in writing within fifteen business days, detailing steps taken, prevention plans, and a timetable for any ongoing corrections. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts.