Cupping Therapy Practice Exam

A suction cup used in a snake bite application is classified as what class of medical device?

1. Class I

2. Class II

3. Class III

4. Class IV

The correct answer is: Class I

In the context of medical devices, a suction cup used in a snake bite application falls under Class I. Class I devices are those which are generally considered to pose a low risk to the user and are subject to the least regulatory controls. They usually do not require premarket notification or approval, although they must comply with general controls, such as registration and good manufacturing practices. Suction cups, including those used for therapeutic purposes, are typically simple in design and function and are made of common materials that pose minimal risk. This aligns well with the classification criteria for Class I devices, making it appropriate for basic tools that serve non-invasive roles in patient care or first aid, such as applying suction to help extract venom in snake bites. In contrast, Class II devices may require more extensive regulatory controls due to their moderate risk, while Class III devices are high-risk devices that usually require premarket approval to demonstrate safety and effectiveness. Class IV does not exist in the context of medical devices as regulated by the FDA. Thus, Class I is the suitable classification for a suction cup used as described.