
Vascular One, Inc.
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VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER is an FDA 510(k)-cleared medical device (K022028) manufactured by Vascular One, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2002. Regulation: 8.