Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart F - Therapeutic Devices / § 878.5910 Pneumatic tourniquet.
§ 878.5910 Pneumatic tourniquet.
(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.