Imani Co.

Imani Co. specializes in electric breast pumps designed for lactating individuals. Their product line includes single-pump systems like the imani i1 and dual-pump models such as the imani i2 and imani i2Plus. These devices are engineered to provide adjustable suction and storage features, catering to the needs of users seeking convenience and efficiency during lactation.

Imani Co. is based in the United States. Their devices are intended for use within the U.S. regulatory framework, where they undergo evaluation through pathways like the FDA’s 510(k) premarket notifications and the Unique Device Identifier (UDI) system.

Imani Co.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of their Class II medical devices, which are subject to specific regulatory oversight in the U.S.

Imani Co.’s electric breast pumps fall under Class II classification according to FDA regulations. This classification is determined based on the risk associated with the device, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. The company’s devices are evaluated through pathways like the 510(k) process to demonstrate compliance with these requirements.