Dongguan Rongfeng Medical Co., Ltd.

Dongguan Rongfeng Medical Co., Ltd. specializes in electric breast pumps. These devices are designed to assist lactating individuals in expressing breast milk manually. The company’s portfolio includes models like GROWNSY, Roabger, monsao, and other electric breast pump variants, all intended for clinical or home use.

The company is based in the US, which means its devices are subject to FDA regulations. Since electric breast pumps fall under Class II classification, they require compliance with FDA pathways like 510(k) clearance and Unique Device Identification (UDI) requirements. The US regulatory framework ensures these devices meet safety and performance standards before entering the market.

The company’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) database. These registries track medical devices that have undergone premarket notification (510(k)) clearance and comply with UDI labeling requirements, ensuring transparency and traceability for Class II devices like electric breast pumps.

The company’s electric breast pumps are classified as Class II devices by the FDA. This classification indicates moderate regulatory oversight, requiring compliance with specific controls to ensure safety and effectiveness. While Class II devices typically do not require premarket approval (PMA), they must still meet 510(k) clearance standards or other applicable pathways to demonstrate substantial equivalence to legally marketed predicate devices.