Zhejiang Luyao Electronics Technology Co., Ltd.

Zhejiang Luyao Electronics Technology Co., Ltd. specializes in pneumatic massage devices, specifically those designed for leg and muscle relaxation. Their products, such as the LUYAO and the Air Compression Leg Massager (Model: LY-670D), use air compression technology to simulate massage therapy. These devices are intended for use in both home and clinical settings to help relieve muscle tension and improve circulation.

The company is based in the United States. While the name suggests a location in China, the regulatory and commercial activities related to its devices are conducted within the U.S. market.

The company’s devices are listed in the FDA’s 510(k) premarket notification registry for certain models, while others are registered under the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. regulatory requirements for medical devices.

The company’s pneumatic massage devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorisation.