Shenzhen Yingzhi Technology Co., Ltd.

Shenzhen Yingzhi Technology Co., Ltd. specializes in magnetic neural stimulation systems, including transcranial magnetic stimulation (TMS) coils, cooling systems for TMS coils, and an electromechanical device transport trolley. Their product line also includes a head marking cap for precise patient positioning and a repetitive transcranial magnetic stimulation (rTMS) device. These devices are designed for therapeutic applications in neuroscience and neurological health.

The company is based in the United States. While the name suggests a Chinese origin, the manufacturer operates from within the US, where it develops and distributes its medical devices. This location ensures compliance with US regulatory requirements for medical device manufacturing and distribution.

Shenzhen Yingzhi Technology Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the United States, ensuring traceability and regulatory compliance. Listing in the UDI database is a requirement for devices marketed in the US.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, as outlined in FDA regulations.

Certain devices, such as the magnetic neural stimulation systems and specialized TMS coils, are classified as Class II because they involve moderate risk. These devices interact directly with the brain or nervous system, where even minor malfunctions could impact patient safety or therapeutic outcomes. FDA requires additional controls, such as performance standards or post-market surveillance, to mitigate these risks.