HEALTH PIXEL SRL

Health Pixel Srl specializes in virtual-display rehabilitation systems focused on upper-limb powered-support. Their primary product, Heaxel, combines virtual reality displays with physical therapy exercises to aid in rehabilitation. The device is designed to assist patients in regaining mobility through interactive, guided movements.

Health Pixel Srl is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under Class II classification, they undergo premarket notification (510(k)) or de novo review processes to ensure compliance with safety and performance standards before entering the market.

Health Pixel Srl’s devices are included in the FDA’s Unique Device Identifier (UDI) database, which tracks medical devices authorized for sale in the U.S. This listing helps ensure traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify product details like manufacturing history and compliance status.

Health Pixel Srl’s products, including Heaxel, are classified as Class II medical devices. This classification is determined by the FDA based on factors like the device’s intended use and potential risk level. Class II devices require premarket submission (such as a 510(k) or de novo request) to demonstrate compliance with applicable regulatory controls before commercial distribution.