SUMMER INFANT (USA), INC.

Summer Infant (USA), Inc. specializes in infant care products, including bundled infant care kits and electronic thermometers. Their devices cover intermittent electronic patient thermometers, which require direct contact, and infrared ear thermometers, which provide quick, non-contact temperature readings. These products are designed to support newborn and young child care by ensuring accurate and convenient temperature monitoring.

Summer Infant (USA), Inc. is headquartered in the United States. Since their devices fall under FDA Class II regulation, they must comply with U.S. regulatory requirements, including registration, listing, and adherence to quality system regulations. This classification applies to their thermometers and infant care kits, ensuring they meet safety and performance standards for their intended use.

Yes, Summer Infant’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is part of the FDA’s efforts to enhance device tracking, transparency, and post-market surveillance. By listing their products here, the company helps ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices like their thermometers.

Summer Infant’s devices are classified as FDA Class II. This classification indicates a moderate level of risk and requires compliance with special controls to ensure their safety and effectiveness. While Class II devices generally do not require pre-market approval, they must still meet specific regulatory requirements, such as performance standards and labeling guidelines, to demonstrate their intended use is met without unreasonable risks.