QGX

General Use Pneumatic Tourniquet

Product code: QGX
Device name: General Use Pneumatic Tourniquet
Device class: Class 1
21 CFR: 21 CFR 878.5910
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K) Exempt

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QGX

Classification and pathway per current FDA publications. Data from openFDA (CC0).