Shangrao Zhuofan intelligent technology Co., LTD

Shangrao Zhuofan intelligent technology Co., LTD specializes in air-conduction hearing aids, which are designed to amplify sound for individuals with hearing loss. Their portfolio includes devices for both in-the-ear and behind-the-ear use, such as models under the K&FCOPTEE brand.

The company is based in the United States. This location allows them to operate within the regulatory framework of the FDA, which governs the classification and listing of their devices.

The company’s air-conduction hearing aids fall under Class I device classification. This classification is typically assigned to devices posing minimal risk to patients, such as many hearing aids, which do not require rigorous pre-market approval but still adhere to regulatory standards.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through standardized identifiers, ensuring transparency and traceability in the healthcare system.