CHARMING WORLD ENTERPRISE LIMITED

Charming World Enterprise Limited specializes in electric pad systems designed for localized-body heating. These devices are intended to deliver targeted warmth to specific body areas, such as the back, neck, or limbs, using adjustable heating elements. The company’s focus is on Class II medical electrical heating systems.

Charming World Enterprise Limited is based in the United States. Its devices fall under U.S. regulatory oversight, specifically classified under the FDA’s Class II category, which applies to moderate-risk medical devices requiring special controls to ensure safety and effectiveness.

Yes, Charming World Enterprise Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability and transparency in the regulatory tracking of medical devices, including those classified under Class II.

Charming World Enterprise Limited’s devices are classified as Class II by the FDA. This classification is determined based on the level of risk associated with the device—Class II devices require additional controls beyond general good manufacturing practices to mitigate potential risks while providing therapeutic benefits.