KPJ — Chamber, Oxygen, Topical, Extremity Class II
FDA product code KPJ covers "Chamber, Oxygen, Topical, Extremity", a Class II medical device regulated under 21 CFR 878.5650. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |