CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART F—Therapeutic Devices (§878.5070 to §878.5910) > 878.5650—Topical oxygen chamber for extremities.

878.5650—Topical oxygen chamber for extremities.

(a) Identification. A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 878.3.