Panels › General, Plastic Surgery › Product code KPJ · Class 2
Chamber, Oxygen, Topical, Extremity
Regulation 878.5650
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KPJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stephenson Industries, Inc. | 3 | 0 |
| Hospitak, Inc. | 2 | 0 |
| Ogenix Corporation | 0 | 2 |
| Vaporox, Inc. | 2 | 0 |
| Adjunctive Therapeutics, Inc. | 1 | 0 |
| Aoti , Ltd. | 1 | 0 |
| Ballard Medical Products | 1 | 0 |
| Electrochemical Oxygen Concepts, Inc. | 1 | 0 |
| Gwr Medical, Llp | 1 | 0 |
| Inotec Amd , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2025 | K250188 | Wound Treatment System (VHT-200) Vaporox, Inc. | KPJ |
| Mar 23, 2023 | K212121 | VHT-200 Wound Treatment System Vaporox, Inc. | KPJ |
| Dec 13, 2019 | K190742 | EPIFLO-28 Neogenix, LLC Dba Ogenix | KPJ |
| Jul 3, 2012 | K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP Inotec Amd , Ltd. | KPJ |
| Apr 27, 2012 | K120764 | EPIFLO(R) Neogenix, LLC | KPJ |
| Aug 12, 2009 | K090681 | TANSCU O2 Electrochemical Oxygen Concepts, Inc. | KPJ |
| Aug 6, 2008 | K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM Aoti , Ltd., IE | KPJ |
| Jun 17, 2005 | K050156 | WHS-1000 WOUND HEALING SYSTEM Iyia Technologies, Inc. | KPJ |
| Feb 24, 2003 | K023456 | OXYBOX SYSTEM Oxyfast Corporation | KPJ |
| Dec 17, 2002 | K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER Vascular One, Inc. | KPJ |
| May 8, 2002 | K020466 | HEC 1000 Metro Medical Equipment, Inc. | KPJ |
| Oct 25, 2001 | K002632 | OXYGENATOR Adjunctive Therapeutics, Inc. | KPJ |
| Feb 3, 1999 | K981949 | NUMOBAG Numotech, Inc. | KPJ |
| Nov 7, 1997 | K971507 | O2 BOOT Gwr Medical, Llp | KPJ |
| Aug 29, 1997 | K960756 | LIFETECH CASSETTE Lifetech Systems, Inc. | KPJ |
| Jul 28, 1997 | K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 Stephenson Industries, Inc. | KPJ |
| Aug 11, 1992 | K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER Topox Therapeuutic Rentals, Inc. | KPJ |
| Mar 2, 1989 | K883848 | KMI OXY-BAN Knight Medical, Inc. | KPJ |
| Nov 28, 1988 | K882461 | O2 CARE Ballard Medical Products | KPJ |
| May 12, 1986 | K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER Stephenson Industries, Inc. | KPJ |
| May 6, 1986 | K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER Stephenson Industries, Inc. | KPJ |
| Apr 25, 1984 | K840817 | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER Hospitak, Inc. | KPJ |
| Oct 27, 1983 | K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM Hospitak, Inc. | KPJ |
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