Splint, Extremity, Noninflatable, External, Sterile

Which Manufacturers in China Make This?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Allmay Bodywear (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Anertai Industrial Limited Guangdong
Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
Hangzhou GspMed Medical Appliances Co., Ltd. Zhejiang, contract manufacturer
Zhejiang Rehan Medical Manufacturing Co., Ltd. Zhejiang

How Is FYH Classified?

Splint, Extremity, Noninflatable, External, Sterile is FDA product code FYH, Class 1, 21 CFR 878.3910.

What Does It Take to Sell It in the United States?

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.

Splint, Extremity, Noninflatable, External, Sterile

Inro Surgical Nail

Nail splint for the reconstructive surgery of the nail bed.

Splint, Extremity, Noninflatable, External, Sterile

SC

Adult Foot AND Ankle Splint

Splint, Extremity, Noninflatable, External, Sterile

Jelco

10 catalogue numbers from HC11, listed by ICU Medical, Inc, United States, under Splint, Extremity, Noninflatable, External, Sterile. 6 manufacturers in China are registered for this product code.

Splint, Extremity, Noninflatable, External, Sterile