Split diffuser oxygen concentrator belongs to the medical device category of products

Hello, on the question of whether the oxygen concentrator is a medical device, the main thing to look at is the use and the related expected effect. It can be judged according to the following definitions:

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.

Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.

The purpose is the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes by the examination of specimens from the human body.

Oxygen generator belonging to the management of medical devices is a Class II medical device, located in the classification directory: 6825 medical high-frequency instrumentation; structure and composition: mainly composed of a compressor, zeolite molecular sieve, changeover switch, control panel, display board, flowmeter, humidification bottle; scope of application: the air as a raw material, the use of molecular sieve pressure-variable adsorption process to produce the range of oxygen concentration of 90% to 96% (V /V) of oxygen (referred to as 93% oxygen).