Utensil, Homemaking

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Anhui and Shanghai, and 1 other province: 9 hold an FDA registration. 1 is a contract manufacturer.

Anhui Yibao Home Textile Co., Ltd. Anhui
China (Shenyang) MED-Land IMP/EXP Corp., Ltd. Shanghai
Fort Metal Plastic Products (Huizhou) Co., Ltd. Guangdong
Gentry Hardware Products Co., Ltd. Guangdong
Gizmospring.com Dongguan Limited Guangdong, contract manufacturer
GuoLong (Shenzhen) High Technology Co., Ltd. Guangdong, contract manufacturer
Ningbo Ningyuan Import & Export Co., Ltd. Zhejiang, contract manufacturer
Shenzhen Zhouyang Medical Care Product Co., Ltd. Guangdong, contract manufacturer
Zengcheng Hua Chang Plastic & Metal Moulding Company Limited Guangdong, contract manufacturer

How Is IKW Classified?

Utensil, Homemaking is FDA product code IKW, Class 1, 21 CFR 890.5050.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

Utensil, Homemaking