FDA WARNING_LETTER - Healing Dives, Inc.

The FDA issued a Warning Letter to Healing Dives, Inc. for marketing hyperbaric chamber accessories without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The FDA's Office of Compliance reviewed the firm's website, http://www.healingdives.com/, and identified the following products as hyperbaric chamber accessories: Air Conditioner, Cooler, Cooler/Silencer, Equalizer, and Oxygen Concentrators.

These products are considered devices under section 201(h) of the Act and are accessories to Class 2 hyperbaric chambers (21 CFR 868.5470). As such, they require submission of a 510(k) premarket notification. The listed products are adulterated under section 501(f)(1)(B) of the Act because Healing Dives, Inc. lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the products into commercial distribution via a 510(k).

Furthermore, Healing Dives, Inc. has not fulfilled annual establishment registration and device listing requirements for fiscal year 2013, as mandated by section 510 of the Act. This renders all of the firm's devices misbranded under section 5