Micromedical Technologies, Inc.

Micromedical Technologies, Inc. makes vision and eye movement analysis systems, including electronystagmographs. Their products include computer eye tracking systems with examination chairs and tables, video eye trackers, video eye monitors, vestibular ocular reflex test equipment (VORTEQ), and rotational vestibular chairs such as the System 2000. These devices are designed for assessing eye movement and vestibular function in clinical settings.

Micromedical Technologies, Inc. is based in the United States. This information is provided directly in the device data summary, which states the company’s country as US. The location is relevant for understanding the regulatory jurisdiction under which its devices are listed and evaluated.

Micromedical Technologies, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries. These listings indicate that the devices have been submitted for premarket notification under Section 510(k) of the Food, Drug, and Cosmetic Act and are assigned unique device identifiers for tracking in the U.S. market. Being listed in these registries does not imply approval; it reflects regulatory submission and identification status.

Micromedical Technologies, Inc.'s devices are classified as Class II medical devices. This classification indicates they pose moderate risk and are subject to special controls such as performance standards, post-market surveillance, and specific labeling requirements. Class II devices typically require a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed device.