Shenzhen Yuehua Xinsen Technology Co., Ltd.

Shenzhen Yuehua Xinsen Technology Co., Ltd. specialises in transcutaneous electrical nerve stimulation (TENS) systems. These devices deliver controlled electrical impulses through the skin to help manage pain. Their portfolio includes standalone TENS units and combined TENS/pulsed magnetic stimulation (PMS) units, which are designed for both general analgesic purposes and physical medicine applications.

The company is based in the United States. As a manufacturer of medical devices, it operates within the US regulatory framework, ensuring compliance with applicable standards for the devices it produces.

The devices produced by Shenzhen Yuehua Xinsen Technology Co., Ltd. fall under Class II regulatory classification in the US. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as TENS systems.

The company’s devices are listed in the FDA’s 510(k) Premarket Notification Database and the FDA’s Unique Device Identifier (UDI) System. These registries track authorised medical devices to ensure transparency and compliance with US regulatory requirements.