HY-VEE, INC.

Hy-Vee, Inc. produces a range of medical devices, including unscented menstrual tampons, automatic-inflation electronic sphygmomanometers (blood pressure monitors) designed for non-portable use, and cryogenic kits for wart removal. Their blood pressure monitors also include wrist-based and multi-user models, with both wired and wireless connectivity options.

Hy-Vee, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s risk-based system. This means compliance with U.S. regulatory requirements is a key consideration for their product development and market authorization.

Hy-Vee, Inc.’s devices are classified as Class II under FDA regulations. This classification is based on the level of risk associated with the devices—Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness. Examples include blood pressure monitors and cryogenic wart-removal kits, which require validation of performance and labeling requirements.

Yes, Hy-Vee, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and patient safety purposes. This listing is mandatory for Class II devices in the U.S.

Hy-Vee, Inc.’s blood pressure monitors are primarily non-portable automatic-inflation electronic sphygmomanometers, designed for stationary use (e.g., home or clinical settings). They include variations like wrist-based models and multi-user devices with wired or wireless connectivity. These features cater to convenience and shared use, but their classification as Class II reflects the need for validated accuracy and safety standards, distinguishing them from simpler manual devices.