KPJ · Chamber, Oxygen, Topical, Extremity
General, Plastic Surgery · 21 CFR 878.5650 · Class 2
Overview
| Product Code | KPJ |
|---|---|
| Device Name | Chamber, Oxygen, Topical, Extremity |
| Regulation | 21 CFR 878.5650 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250188 | Wound Treatment System (VHT-200) | Vaporox, Inc. | Mar 10, 2025 | SESE |
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | Mar 23, 2023 | SESE |
| K190742 | EPIFLO-28 | Neogenix, LLC Dba Ogenix | Dec 13, 2019 | SESE |
| K112634 | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | Jul 3, 2012 | SESE |
| K120764 | EPIFLO(R) | Neogenix, LLC | Apr 27, 2012 | SESE |
| K090681 | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | Aug 12, 2009 | SESE |
| K080966 | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | Aug 6, 2008 | SESE |
| K050156 | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | Jun 17, 2005 | SESE |
| K023456 | OXYBOX SYSTEM | Oxyfast Corporation | Feb 24, 2003 | SESE |
| K022028 | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | Dec 17, 2002 | SESE |
| K020466 | HEC 1000 | Metro Medical Equipment, Inc. | May 8, 2002 | SESE |
| K002632 | OXYGENATOR | Adjunctive Therapeutics, Inc. | Oct 25, 2001 | SESE |
| K981949 | NUMOBAG | Numotech, Inc. | Feb 3, 1999 | SESE |
| K971507 | O2 BOOT | Gwr Medical, Llp | Nov 7, 1997 | SESE |
| K960756 | LIFETECH CASSETTE | Lifetech Systems, Inc. | Aug 29, 1997 | SESE |
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Stephenson Industries, Inc. | Jul 28, 1997 | SESE |
| K920948 | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Topox Therapeuutic Rentals, Inc. | Aug 11, 1992 | SESE |
| K883848 | KMI OXY-BAN | Knight Medical, Inc. | Mar 2, 1989 | SN |
| K882461 | O2 CARE | Ballard Medical Products | Nov 28, 1988 | SN |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | May 12, 1986 | SESE |
Top Applicants
- Stephenson Industries, Inc. — 3 clearances
- Hospitak, Inc. — 2 clearances
- Vaporox, Inc. — 2 clearances
- Adjunctive Therapeutics, Inc. — 1 clearance
- Aoti , Ltd. — 1 clearance
