Shen Zhen Rong Feng Technology Co., Ltd.

Shen Zhen Rong Feng Technology Co., Ltd. specializes in intermittent electronic patient thermometers and infrared skin thermometers. These devices are designed to measure body temperature in both clinical and home environments, ensuring accurate readings for patient monitoring.

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

The devices produced by Shen Zhen Rong Feng Technology Co., Ltd., including intermittent electronic patient thermometers and infrared skin thermometers, are classified as Class II under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

The company’s devices are listed in the FDA’s 510(k) Premarket Notification Database and the FDA’s Unique Device Identifier (UDI) System. These registries ensure transparency and traceability of medical devices, allowing healthcare providers and regulators to verify compliance and device details.

The classification of these thermometers as Class II is due to their role in measuring critical patient data—body temperature—which can impact clinical decisions. While Class I devices generally pose minimal risk, thermometers require additional controls (such as performance standards or post-market surveillance) to ensure accuracy and reliability, justifying their placement in Class II.