EKT LLC

EKT LLC specializes in handgrip disability-assistive walkers, specifically non-powered, foldable models. These devices are designed to aid individuals with mobility limitations by offering stability and support during walking, suitable for both indoor and outdoor use. The focus is on assistive mobility solutions rather than active or motorized devices.

EKT LLC is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under FDA Class I classification, they are generally considered lower risk but still require compliance with FDA requirements, including listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and transparency in the medical device supply chain.

EKT LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a mandatory registry for medical devices in the U.S. This database helps track and identify devices throughout their lifecycle, ensuring compliance with FDA regulations. While Class I devices typically require less stringent premarket review, UDI listing remains a key requirement for transparency and recall management.

EKT LLC’s devices are classified as FDA Class I, which is the lowest risk category for medical devices. This classification applies because the products—foldable, non-powered walkers—pose minimal risk to patients when used as intended. Class I devices still require compliance with general controls (e.g., labeling, manufacturing practices) and UDI listing, but they do not typically undergo a formal premarket approval process. The classification reflects the device’s safety profile and streamlines regulatory oversight.