Chamber, Oxygen, Topical, Extremity
This device is a topical oxygen chamber designed to enclose an extremity and deliver concentrated oxygen directly to the wound surface, used to promote healing in chronic or non-healing wounds of the limbs. It is classified as FDA Class 2, indicating moderate risk, requiring 510(k) premarket notification. The product code is KPJ, regulated under 21 CFR 878.5650 within the General and Plastic Surgery specialty. No special flags apply.
Basic Information
- Product Code
- KPJ
- Device Class
- FDA class 2
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Mar 10, 2025 | Substantially Equivalent | Vaporox, Inc. |
| K212121 | VHT-200 Wound Treatment System | Mar 23, 2023 | Substantially Equivalent | Vaporox, Inc. |
| K190742 | EPIFLO-28 | Dec 13, 2019 | Substantially Equivalent | Neogenix, LLC dba Ogenix |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Jul 03, 2012 | Substantially Equivalent | INOTEC AMD LTD. |
| K120764 | EPIFLO(R) | Apr 27, 2012 | Substantially Equivalent | NEOGENIX, LLC |
| K090681 | TANSCU O2 | Aug 12, 2009 | Substantially Equivalent | ELECTROCHEMICAL OXYGEN CONCEPTS, INC. |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aug 06, 2008 | Substantially Equivalent | AOTI LTD. |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Jun 17, 2005 | Substantially Equivalent | IYIA TECHNOLOGIES, INC. |
| K023456 | OXYBOX SYSTEM | Feb 24, 2003 | Substantially Equivalent | OXYFAST CORPORATION |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Dec 17, 2002 | Substantially Equivalent | VASCULAR ONE, INC. |
| K020466 | HEC 1000 | May 08, 2002 | Substantially Equivalent | METRO MEDICAL EQUIPMENT, INC. |
| K002632 | OXYGENATOR | Oct 25, 2001 | Substantially Equivalent | ADJUNCTIVE THERAPEUTICS, INC. |
| K981949 | NUMOBAG | Feb 03, 1999 | Substantially Equivalent | NUMOTECH, INC. |
| K971507 | O2 BOOT | Nov 07, 1997 | Substantially Equivalent | GWR MEDICAL, LLP |
| K960756 | LIFETECH CASSETTE | Aug 29, 1997 | Substantially Equivalent | LIFETECH SYSTEMS, INC. |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Jul 28, 1997 | Substantially Equivalent | STEPHENSON INDUSTRIES, INC. |
| K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Aug 11, 1992 | Substantially Equivalent | TOPOX THERAPEUUTIC RENTALS, INC. |
| K883848 | KMI OXY-BAN | Mar 02, 1989 | Substantially Equivalent for Some Indications | KNIGHT MEDICAL, INC. |
| K882461 | O2 CARE | Nov 28, 1988 | Substantially Equivalent for Some Indications | BALLARD MEDICAL PRODUCTS |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | May 12, 1986 | Substantially Equivalent | STEPHENSON INDUSTRIES, INC. |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | May 06, 1986 | Substantially Equivalent | STEPHENSON INDUSTRIES, INC. |
| K840817 | DISPOSABLE, HYPERBARIC OXYGEN CHAMBER | Apr 25, 1984 | Substantially Equivalent | HOSPITAK, INC. |
| K831825 | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM | Oct 27, 1983 | Substantially Equivalent | HOSPITAK, INC. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.