Splint, Denis Brown

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Fujian, Guangdong and Hebei: 3 hold an FDA registration. 2 are contract manufacturers.

Beijing Jinwei Kangda Medical Instrument Ltd. Hebei, contract manufacturer
Dongguan Vigor Textile Co., Ltd. Guangdong, contract manufacturer
Putian Lake Sports Goods Co., Ltd. Fujian

How Is ITN Classified?

Splint, Denis Brown is FDA product code ITN, Class 1, 21 CFR 890.3675.

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.

Splint, Denis Brown

Mitchell Ponseti® Bracing System

Catalogue number HDWEKIT, listed by MD Orthopaedics, United States, under Splint, Denis Brown. 3 manufacturers in China are registered for this product code.

Splint, Denis Brown