Dong Guan Ou Kang Electronics CO., LTD

Dong Guan Ou Kang Electronics CO., LTD specializes in producing single-use transcutaneous electrical stimulation (TENS) electrodes. These electrodes are designed for temporary skin contact during therapeutic electrical stimulation procedures, ensuring disposable use to maintain hygiene and safety.

The company is based in the United States, though its manufacturing origins may trace back to its original location in Dong Guan, China. The U.S. presence is relevant for regulatory compliance and market distribution.

The company’s TENS electrodes fall under Class II regulatory classification. This classification typically applies to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to identify and verify the devices’ specifications and compliance status.