Elidah, Inc.

Elidah, Inc. specializes in transcutaneous incontinence-control electrical stimulators and their associated electrode pads. These devices are designed to help manage urinary incontinence, including urge incontinence, by delivering controlled electrical impulses through the skin to stimulate muscle responses that improve bladder control.

Elidah, Inc. is based in the United States. Since the company operates domestically, its devices must comply with U.S. regulatory requirements, including FDA pathways such as the 510(k) premarket notification process and Unique Device Identifier (UDI) listings. The U.S. regulatory framework governs the classification, authorisation, and post-market surveillance of these medical devices.

Elidah, Inc.’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk, requiring specific controls to ensure safety and effectiveness. Class II devices typically undergo a 510(k) premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards before entering the market.

Elidah, Inc.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries are critical for tracking device authorisations, compliance, and post-market reporting. The 510(k) listing confirms regulatory clearance, while the UDI ensures traceability and transparency in the supply chain.

The FDA’s 510(k) pathway is used for Class II devices like Elidah’s transcutaneous electrical stimulators because it demonstrates substantial equivalence to a previously authorised predicate device. This means the new device has the same intended use, technological characteristics, and performance as an existing approved device, allowing the FDA to rely on prior safety and effectiveness data while still ensuring compliance with updated standards.