Not a drug, belongs to a class of medical devices, 6858 medical cold therapy, cryogenic, refrigeration equipment and apparatus. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is obtained mainly through physical and other means, not through pharmacological, immunological or metabolic means, or although these means are involved but only play a supporting role; their purpose is:
(i) the diagnosis, prevention, monitoring, treatment, or alleviation of disease;
(ii) the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury;
(iii) the testing, substitution, modulation, or support of physiological structures or processes;
(iv) the support or maintenance of life;
(v) pregnancy control;
< p>(vi) Providing information for medical or diagnostic purposes through the examination of samples from the human body.