Medical devices in the US are regulated based on an FDA classification system that evaluates the level of benefit and risk posed by the product and the level of control needed to ensure adequate safety. Classification is generally established based on its intended use (its general purpose or function) and indications for use (the disease or condition it is designed to diagnose, treat, prevent, cure or mitigate). Class I medical devices are subject to the FDA’s general controls and “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.” Class I devices have a low impact on patients’ overall health and do not come into contact with their organs, the central nervous system or the cardiovascular system. Class I devices present minimal harm to the patient and are generally simple in design.

We, at PolyHealth, offer a wide variety of Class I products like oxygen masks, needle free connectors, irrigation sets, urine collection bags, etc. These products support healthcare professionals in providing safe and quality care to the patients.