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FDA Statement & Legal Notice
OxyHealth chambers are a Class II medical device. As indicated in the FDA 510(K) clearance, these chambersóboth the portable mild and steel typesóare prescription devices.
FDA regulations require that the chambers be sold to or on the order of a state licensed practitioner.
OxyHealth, LLC Pursuant to FDA Warning Letter #406207, OxyHealth has always maintained 510(k) clearance and approval from the FDA to market and retail portable hyperbaric chambers to the public at large, since its inception. No violation was present and no corrective actions were taken, as OxyHealth invariably sustains legal and ethical business practices to ensure lawful amenability towards consumer compliance in accordance with FDA rules and regulations. OxyHealth has been formally cleared according to the April, 8 2014 FDA Close Out Letter.
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