LUCKY DRAGON ENTERPRISE GROUP INC.

Lucky Dragon Enterprise Group Inc. specializes in external manual massagers intended for home use. These devices are designed to provide muscle relief and relaxation through manual stimulation, targeting consumer needs for at-home wellness solutions.

The company is headquartered in the United States. This location influences its regulatory compliance and distribution channels, particularly for devices marketed within North America.

Lucky Dragon Enterprise Group Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for commercial distribution in the U.S., ensuring traceability and compliance.

The company’s devices fall under Class I classification, which is the lowest risk category for medical devices. This classification applies to products like external manual massagers that pose minimal risk to users, allowing them to be marketed without pre-market approval, though they must still comply with FDA listing requirements.