Component, Cast
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Zhejiang, Jiangsu and Anhui, and 4 other provinces: 22 hold an FDA registration. 6 are contract manufacturers.
- Anji Hongli Import & Export Co., Ltd. Zhejiang
- Anji Fang Yuan Sanitary Material Co., Ltd. Zhejiang
- Anji Hengfeng Sanitary Material Co., Ltd. Zhejiang, contract manufacturer
- Anji Hongde Medical Products Co., Ltd. Zhejiang, contract manufacturer
- Anhui Kangfu Industrial Foreign Trade Co., Ltd. Anhui, contract manufacturer
- Boen Healthcare Co., Ltd. Jiangsu
- Fengtai County Guqiao Town Changxing Shoe Factory Anhui, contract manufacturer
- Hangzhou Goals Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Tuopusi Medical Products Co., Ltd. Zhejiang
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
- Jiangsu Likang Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Jiujiang Huada Medical Dressing Co., Ltd. Jiangxi, contract manufacturer
- Medstar Healthcare Co., Limited Zhejiang
- Shaanxi Ansen Medical Technology Development Co., Ltd. Shaanxi, contract manufacturer
- Suzhou EMY Medical Supplies Co., Ltd. Jiangsu
- Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
- Shanghai Joy Crown Industry Co., Ltd. Shanghai, contract manufacturer
- Wuhan Zonsen Medical Products Co., Ltd. Hubei, contract manufacturer
- Wuxi Goals Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Zhejiang Anji Huabu Industrial Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Medicines & Health Products I/ E Co., Ltd. Zhejiang
How Is LGF Classified?
Component, Cast is FDA product code LGF, Class 1, 21 CFR 888.5940.
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.
Name
Record
CastWedge™
(30 mm) CastWedge™ Cast Adjuster. Designed for cast realignment and swelling relief. Use with plaster or fiberglass cast.