Rongfeng breast pump has obtained FDA 510K certification approval
K212884
Electric breast pumps are classified as Class II medical devices in the United States Medical devices and products need to comply with the US FDA's regulations on medicine Requirements for medical equipment.
The purpose of an electric breast pump is to allow lactating women to secrete and collect milk from their breasts. It is designed for individual users.
The electric breast pump forms a sealed area around the nipple by sucking on accessories, and the air inside the sealed area is pumped away by the air pump, creating a vacuum and applying suction to the breast,
Then release suction to stimulate lactation and extract milk. Milk is collected in the bottle.
Due to the busy workload, more and more breastfeeding women choose to participate in work during their lactation period, and the use of electric breast pumps is safe Fully hygienic and convenient,
Rongfeng has chosen to entrust us to handle the registration of their company's FDA 510K certification in the United States. Rui Enni fulfilled the client's commission and completed the approval of FDA 510K certification at the beginning of 2022.
After this registration, there are several experiences that need to be shared, including:
1) The breast pump is suitable for lactating women, single patient use, and needs to be cleaned and disinfected before use Poison;
2) The testing of vacuum negative pressure needs to be ensured during operation;
3) The instructions for using the breast pump need to comply with the requirements of the US Centers for Disease Control and Prevention.
