Chung Cheng Electric Heating Co., Ltd.

Chung Cheng Electric Heating Co., Ltd. specializes in non-wearable infrared phototherapy units, specifically designed for musculoskeletal applications. These devices, such as the Relax and the CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (Model CH-8810), emit far-infrared radiation to target soft tissues and joints for therapeutic purposes. The focus is on devices that provide localized heat and infrared therapy without requiring the user to wear them.

The company, Chung Cheng Electric Heating Co., Ltd., is based in the United States. This location is relevant for regulatory oversight and compliance, as it aligns with the FDA’s jurisdiction over medical devices marketed in the U.S. The company’s U.S. presence also influences its participation in regulatory registries and clearance processes.

Chung Cheng Electric Heating Co., Ltd.’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries are critical for tracking and verifying the compliance and authorization status of Class II medical devices, ensuring transparency and accountability in the healthcare industry. The 510(k) process demonstrates that the devices meet FDA requirements for safety and effectiveness.

Chung Cheng Electric Heating Co., Ltd.’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. The classification reflects the need for regulated oversight without the stringent requirements of Class III devices.