21 C.F.R. § 878.5650 Topical oxygen chamber for extremities.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart F—Therapeutic Devices
§ 878.5650 Topical oxygen chamber for extremities.
