Resilia, Inc.

Resilia, Inc. specializes in reusable vaginal inserts primarily designed to help manage urinary incontinence. These devices provide pelvic floor support for women experiencing stress or mild urge incontinence as a non-surgical option. The company’s focus is on this specific category of incontinence management.

Resilia, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these reusable vaginal inserts as Class II, which requires compliance with pre-market notification (510(k)) submissions and adherence to the Unique Device Identifier (UDI) system to ensure safety and effectiveness.

Resilia, Inc.’s devices are listed in the FDA’s regulatory databases, specifically under the pre-market notification (510(k)) and Unique Device Identifier (UDI) systems. These registries ensure transparency and compliance tracking for Class II medical devices, including reusable vaginal incontinence inserts like those manufactured by Resilia.

Resilia, Inc.’s devices are classified as FDA Class II, which means they are considered to have a moderate level of risk. This classification requires manufacturers to submit a 510(k) pre-market notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. Additionally, compliance with the UDI system is mandatory for tracking and traceability, ensuring patient safety and regulatory oversight.