ZOE RUTH

Zoe Ruth specializes in infrared thermometers designed to measure body temperature. Their devices include non-contact and contact models that read temperature via the ear or skin, such as forehead and ear thermometers. These products are intended for both clinical and home use, offering quick, contact-free or minimal-contact temperature assessments.

Zoe Ruth is based in the United States, which means their devices must comply with FDA regulations. Since their products fall under Class II classification, they are subject to special controls and may require premarket notifications (510(k)) or other regulatory pathways depending on the specific design and intended use. The U.S. location also influences their participation in registries like the FDA’s UDI database.

Zoe Ruth’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring traceability for regulatory purposes, patient safety, and supply chain management. Listing in the UDI database helps healthcare providers and regulators verify the device’s identity and compliance status.

Zoe Ruth’s devices are classified as Class II under FDA regulations. This classification indicates that while they pose a moderate risk, they require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket submissions (like 510(k)s) to demonstrate compliance with these controls, which may include performance standards, labeling requirements, or post-market surveillance measures.