TOPICAL HYPERBARIC OXYGEN CHAMBER
Device Facts
| Record ID | K861593 |
|---|---|
| Device Name | TOPICAL HYPERBARIC OXYGEN CHAMBER |
| Applicant | Stephenson Industries, Inc. |
| Product Code | KPJ · General, Plastic Surgery |
| Decision Date | May 12, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5650 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
