FDA 510(k) Applications for Medical Device Product Code "KPJ"
(Chamber, Oxygen, Topical, Extremity)

FDA 510(k) Number Applicant Device Name Decision Date
K002632 ADJUNCTIVE THERAPEUTICS, INC. OXYGENATOR 10/25/2001
K080966 AOTI LTD. HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM 08/06/2008
K090681 ELECTROCHEMICAL OXYGEN CONCEPTS, INC. TANSCU O2 08/12/2009
K971507 GWR MEDICAL, LLP O2 BOOT 11/07/1997
K112634 INOTEC AMD LTD. NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP 07/03/2012
K050156 IYIA TECHNOLOGIES, INC. WHS-1000 WOUND HEALING SYSTEM 06/17/2005
K960756 LIFETECH SYSTEMS, INC. LIFETECH CASSETTE 08/29/1997
K020466 METRO MEDICAL EQUIPMENT, INC. HEC 1000 05/08/2002
K120764 NEOGENIX, LLC EPIFLO(R) 04/27/2012
K190742 Neogenix, LLC dba Ogenix EPIFLO-28 12/13/2019
K981949 NUMOTECH, INC. NUMOBAG 02/03/1999
K023456 OXYFAST CORPORATION OXYBOX SYSTEM 02/24/2003
K963777 STEPHENSON INDUSTRIES, INC. HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 07/28/1997
K212121 Vaporox, Inc. VHT-200 Wound Treatment System 03/23/2023
K022028 VASCULAR ONE, INC. VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER 12/17/2002


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