Wheelchairs and infusion devices are categorized as which class of devices?

Wheelchairs and infusion devices are categorized as Class II medical devices. This classification is significant as it indicates that these devices are subject to certain regulatory controls to ensure their safety and effectiveness. Class II devices are typically those that are moderate-risk and require a premarket notification, also known as a 510(k), to demonstrate that they are substantially equivalent to a device already on the market.

Devices like wheelchairs and infusion devices often have specific performance standards or requirements that manufacturers must meet, including any labeling requirements and potential post-marketing surveillance. These controls help minimize the risks associated with the devices while allowing for faster market entry compared to high-risk Class III devices, which generally require more extensive clinical testing and a premarket approval process.

In summary, the classification of wheelchairs and infusion devices as Class II reflects their risk level and the regulatory framework designed to protect patient safety while ensuring access to these important medical tools.