Instrument, Cast Removal, Ac-Powered

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Jiangsu and Zhejiang: 4 hold an FDA registration. 1 is a contract manufacturer.

Derma Sciences Nantong Incorporation Jiangsu, contract manufacturer
Hangzhou Zhengda Medical Co., Ltd. Zhejiang, contract manufacturer
Jiangsu Senolo Medical Technology Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Longyou Landmedical Technology Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code LGH?

Instrument, Cast Removal, Ac-Powered is FDA product code LGH, Class 1, 21 CFR 888.5960.

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.

Instrument, Cast Removal, Ac-Powered

Delta-Cast Serene

Delta-Cast® Serene™ is a cast removal device that provides the needed power, precision, and ease of operation to cut Synthetic Casts that have been applied to a limb. Delta-Cast® Serene™ is…

Instrument, Cast Removal, Ac-Powered