Code of Federal Regulations Title 21. Food and Drugs § 21.880.5430 Nonelectrically powered fluid injector

(a) Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

(b) Classification. Class II (performance standards).