21 CFR 878.5650 — Chamber, Oxygen, Topical, Extremity
General, Plastic Surgery (SU) · Part 878 Subpart F—Therapeutic Devices · § 878.5650
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | 2 | 23 |
Special Controls
KPJ — Chamber, Oxygen, Topical, Extremity
*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.
eCFR
KPJ — Chamber, Oxygen, Topical, Extremity
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.
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