Limerick, Inc.

Limerick, Inc. specializes in electric breast pumps. These devices are designed to assist lactating individuals in expressing milk, and their portfolio includes both portable and stationary models. Examples include battery-powered and mains-powered pumps like the Limerick Powered Electric Breast Pump Model 1002 and the PJ’s Comfort Jr Portable Electric Breast Pump. The company focuses exclusively on this category of devices.

Limerick, Inc. is based in Limerick, US. As a US-based manufacturer, its devices fall under the jurisdiction of the US Food and Drug Administration (FDA). The company must comply with FDA regulations applicable to electric breast pumps, including classification, registration, and listing requirements. The location also determines which regulatory pathways (e.g., 510(k) submissions or UDI compliance) apply to its products.

Limerick, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The 510(k) pathway is used for Class II devices like their breast pumps to demonstrate substantial equivalence to a legally marketed predicate device. The UDI system ensures traceability and transparency in the supply chain, which is mandatory for medical devices in the US to improve patient safety and regulatory oversight.

Limerick, Inc.’s electric breast pumps are classified as Class II devices under US regulations. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. While Class II devices do not require pre-market approval like Class III devices, they must comply with specific FDA regulations, such as 510(k) clearance, labeling requirements, and post-market surveillance, to maintain their authorised status.