Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5650](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5650) → KPJ — Chamber, Oxygen, Topical, Extremity # KPJ · Chamber, Oxygen, Topical, Extremity _General, Plastic Surgery · 21 CFR 878.5650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ ## Overview - **Product Code:** KPJ - **Device Name:** Chamber, Oxygen, Topical, Extremity - **Regulation:** [21 CFR 878.5650](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5650) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K250188.md) | Wound Treatment System (VHT-200) | Vaporox, Inc. | Mar 10, 2025 | SESE | | [K212121](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K212121.md) | VHT-200 Wound Treatment System | Vaporox, Inc. | Mar 23, 2023 | SESE | | [K190742](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K190742.md) | EPIFLO-28 | Neogenix, LLC Dba Ogenix | Dec 13, 2019 | SESE | | [K112634](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K112634.md) | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP | Inotec Amd , Ltd. | Jul 3, 2012 | SESE | | [K120764](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K120764.md) | EPIFLO(R) | Neogenix, LLC | Apr 27, 2012 | SESE | | [K090681](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K090681.md) | TANSCU O2 | Electrochemical Oxygen Concepts, Inc. | Aug 12, 2009 | SESE | | [K080966](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K080966.md) | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM | Aoti , Ltd. | Aug 6, 2008 | SESE | | [K050156](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K050156.md) | WHS-1000 WOUND HEALING SYSTEM | Iyia Technologies, Inc. | Jun 17, 2005 | SESE | | [K023456](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K023456.md) | OXYBOX SYSTEM | Oxyfast Corporation | Feb 24, 2003 | SESE | | [K022028](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K022028.md) | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER | Vascular One, Inc. | Dec 17, 2002 | SESE | | [K020466](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K020466.md) | HEC 1000 | Metro Medical Equipment, Inc. | May 8, 2002 | SESE | | [K002632](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K002632.md) | OXYGENATOR | Adjunctive Therapeutics, Inc. | Oct 25, 2001 | SESE | | [K981949](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K981949.md) | NUMOBAG | Numotech, Inc. | Feb 3, 1999 | SESE | | [K971507](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K971507.md) | O2 BOOT | Gwr Medical, Llp | Nov 7, 1997 | SESE | | [K960756](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K960756.md) | LIFETECH CASSETTE | Lifetech Systems, Inc. | Aug 29, 1997 | SESE | | [K963777](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K963777.md) | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 | Stephenson Industries, Inc. | Jul 28, 1997 | SESE | | [K920948](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K920948.md) | TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER | Topox Therapeuutic Rentals, Inc. | Aug 11, 1992 | SESE | | [K883848](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K883848.md) | KMI OXY-BAN | Knight Medical, Inc. | Mar 2, 1989 | SN | | [K882461](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K882461.md) | O2 CARE | Ballard Medical Products | Nov 28, 1988 | SN | | [K861593](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K861593.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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