Possum, Inc.

Possum, Inc. specializes in mechanical and electronic devices designed to improve accessibility and security. Their product line includes assistive devices like a page-turning assist device for individuals with limited mobility, typewriter control systems for users with physical impairments, and environmental control systems that allow users to manage room temperature and lighting. They also produce independent emergency alarm systems and intercom door locks for secure communication and access control.

Possum, Inc. is based in the United States. Since the company operates within the U.S., its devices fall under the jurisdiction of the FDA. The regulatory framework for medical devices in the U.S. requires compliance with specific classifications, and Possum’s products are authorised through pathways like the 510(k) premarket notification process, which is commonly used for devices classified as Class I or Class II.

Possum, Inc.’s medical devices are listed in the FDA’s 510(k) database. This registry includes devices that have been authorised through the 510(k) premarket notification process, which is a key pathway for certain Class I and Class II devices to demonstrate substantial equivalence to legally marketed predicates. Listing in this database confirms the device’s regulatory status under U.S. law.

Possum, Inc.’s devices are classified under FDA’s Class I and Class II categories. Classification determines the regulatory controls applied to a device. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls in addition to general controls. The classification influences the authorisation pathway—such as the 510(k) process—and the level of scrutiny the device undergoes before being authorised.