Marvelworks Limited

Marvelworks Limited specializes in incontinence sensors and alarm systems. These devices are designed to detect urinary incontinence events and provide real-time alerts to help users manage bladder control issues at home. The focus is on improving quality of life for individuals dealing with incontinence.

Marvelworks Limited is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those listed in the FDA’s Unique Device Identifier (UDI) database.

Marvelworks Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Marvelworks Limited’s incontinence sensors and alarm systems fall under FDA Class II medical devices. This classification indicates that while the devices pose moderate risk, they require special controls to ensure safety and effectiveness, such as performance testing and labeling requirements.