KPJ — Chamber, Oxygen, Topical, Extremity Class II
FDA Device Classification
Classification Details
- Product Code
- KPJ
- Device Class
- Class II
- Regulation Number
- 878.5650
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250188 | vaporox | Wound Treatment System (VHT-200) | March 10, 2025 |
| K212121 | vaporox | VHT-200 Wound Treatment System | March 23, 2023 |
| K190742 | neogenix, llc dba ogenix | EPIFLO-28 | December 13, 2019 |
| K112634 | inotec amd | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | July 3, 2012 |
| K120764 | neogenix | EPIFLO(R) | April 27, 2012 |
| K090681 | electrochemical oxygen concepts | TANSCU O2 | August 12, 2009 |
| K080966 | aoti | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | August 6, 2008 |
| K050156 | iyia technologies | WHS-1000 WOUND HEALING SYSTEM | June 17, 2005 |
| K023456 | oxyfast corporation | OXYBOX SYSTEM | February 24, 2003 |
| K022028 | vascular one | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | December 17, 2002 |
| K020466 | metro medical equipment | HEC 1000 | May 8, 2002 |
| K002632 | adjunctive therapeutics | OXYGENATOR | October 25, 2001 |
| K981949 | numotech | NUMOBAG | February 3, 1999 |
| K971507 | gwr medical | O2 BOOT | November 7, 1997 |
| K960756 | lifetech systems | LIFETECH CASSETTE | August 29, 1997 |
| K963777 | stephenson industries | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | July 28, 1997 |
| K920948 | topox therapeuutic rentals | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | August 11, 1992 |
| K883848 | knight medical | KMI OXY-BAN | March 2, 1989 |
| K882461 | ballard medical products | O2 CARE | November 28, 1988 |
| K861593 | stephenson industries | TOPICAL HYPERBARIC OXYGEN CHAMBER | May 12, 1986 |