The US FDA defines Class I devices as devices which are "not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury."
These devices are the most common Class of devices regulated by the FDA, constituting 47 percent of approved devices on the market.
Class I devices have minimal contact with patients and low impact on a patient's overall health. In general, Class I devices do not come into contact with a patient's internal organs, the central nervous system, or cardiovascular system. These devices are subject to the fewest regulatory requirements.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
