DIGITAL HEAT CORPORATION

Digital Heat Corporation manufactures reusable eye heat therapy packs, including the Heated Eye Pad, Heated Eye Pad Pro, and OCuSOFT Thermal 1-Touch. These products are designed to deliver controlled heat to the eye area for therapeutic purposes, such as relieving dry eye symptoms or meibomian gland dysfunction. The company focuses exclusively on this product type, as indicated in the device data, and does not produce other medical devices outside this category.

Digital Heat Corporation is based in the United States (US), as specified in the device data under the COUNTRY field. The company’s location is limited to this geographic detail, with no further information provided about specific states, cities, or facilities. This base location informs regulatory jurisdiction but does not imply any approval or certification of the company itself.

Digital Heat Corporation's devices are listed in the FDA 510(k) and FDA UDI registries, as stated in the LISTED IN field of the device data. These registries track device submissions and unique device identifiers for regulatory tracking in the U.S. market. Listing in these systems indicates that the devices have undergone FDA review processes, but it does not mean the company is approved—only that individual devices are authorized for marketing under applicable regulations.

Digital Heat Corporation's devices are classified as Class II medical devices, according to the DEVICE CLASSES field in the device data. Class II devices are subject to special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements. This classification applies to all listed products, including the Heated Eye Pad, Heated Eye Pad Pro, and OCuSOFT Thermal 1-Touch, and reflects their moderate risk profile under FDA regulations.