TOLT Technologies LLC

Tolt Technologies LLC specializes in mobility assistance devices. Their primary product, the Ability Drive, is designed to help users with limited mobility achieve greater independence during movement. This device is intended for personal use in both home and community environments, focusing on providing enhanced stability and control.

Tolt Technologies LLC is based in the United States. Since their devices are manufactured there, they fall under the regulatory oversight of the U.S. Food and Drug Administration (FDA). Additionally, their products are registered in the EU’s eudamed database, indicating compliance with EU medical device regulations where applicable.

The Ability Drive, Tolt Technologies LLC’s primary device, is classified as a Class I medical device. This classification is typically assigned to low-risk products, such as mobility aids, where the risk to the user is minimal. The classification determines regulatory requirements, including registration, labeling, and post-market surveillance obligations.

Tolt Technologies LLC’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry tracks manufacturers, devices, and clinical investigations within the EU market. While eudamed is an EU-specific system, it reflects the company’s compliance with EU regulatory requirements for their products.