Final answer:
A Class 1 or Class 2 medical device refers to the categorization of medical devices based on their risk level and the amount of regulation they require for clearance or approval.
Step-by-step explanation:
A Class 1 or Class 2 medical device refers to the categorization of medical devices based on their risk level and the amount of regulation they require for clearance or approval.
Class 1 medical devices are low-risk devices that are simpler in design and pose minimal harm to the user. Examples include bandages, gloves, and tongue depressors. These devices may not require premarket approval and are subject to general controls.
Class 2 medical devices are moderate-risk devices that are more complex in design and may have potential risks to the user. Examples include powered wheelchairs, hearing aids, and surgical gloves. These devices require a premarket notification, also known as 510(k) clearance, to demonstrate substantial equivalence to a predicate device already on the market.