Equipment refers to instruments, devices, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software.

Equipment and medical supplies are included.

Effectiveness is primarily achieved through physical means, not via pharmacology, immunology, or metabolism, or although these methods may be involved, they only play a supplementary role.

The purpose is the diagnosis, prevention, monitoring, and relief of diseases; the diagnosis, monitoring, relief, or functional compensation of injuries; examination, substitution, adjustment, or support of physiological structures or processes; life support or maintenance; pregnancy control; and providing information for diagnostic purposes through examination of samples from the human body.