Shenzhen XFT Medical Limited

Shenzhen XFT Medical Limited makes physical therapy devices, specifically transcutaneous neuromuscular electrical stimulation systems, such as the Aspire device. These devices apply electrical stimulation for therapeutic purposes in physical therapy settings. The company's products are medical devices designed to assist with muscle stimulation and rehabilitation, and they are regulated as Class II devices under U.S. regulatory oversight.

Shenzhen XFT Medical Limited is based in the United States, as indicated in the provided data. The company operates within the U.S. regulatory framework, and its devices are subject to oversight by U.S. authorities. This location determines the regulatory pathway under which its devices are evaluated and listed, particularly in relation to FDA requirements.

Shenzhen XFT Medical Limited's devices are listed in the FDA UDI registry. This registry is used to track medical devices sold in the United States through unique device identifiers. The listing in this system confirms that the company's devices, such as the Aspire transcutaneous neuromuscular electrical stimulation system, are registered for distribution in the U.S. market under applicable regulations.

Shenzhen XFT Medical Limited's devices are classified as Class II medical devices. This classification indicates that they pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements. The Class II designation applies to products like the Aspire transcutaneous neuromuscular electrical stimulation system, which are subject to FDA regulatory oversight.