Elite Brite
3 catalogue numbers from universal, listed by Hengshui Tianjian Medical Supplies Co., Ltd., China, under Sling, Arm, Overhead Supported. 31 manufacturers in China are registered for this product code.
Sling, Arm, Overhead Supported
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Fujian and Jiangsu, and 5 other provinces: 31 hold an FDA registration. 6 are contract manufacturers.
- Abletech Orthopedics Corporation Taiwan, contract manufacturer
- AID United International Co., Limited Shanghai
- Allmay Bodywear (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Dongguan Ellian Enterprise, Ltd. Guangdong, contract manufacturer
- Dongguan NAN YOU Sporting Goods Enterprise Ltd Guangdong, contract manufacturer
- Dongguan Redthera Technology Co., Ltd. Guangdong
- Dongguan SafeSecure Plastics Co., Ltd. Guangdong, contract manufacturer
- Dongguan Vigor Textile Co., Ltd. Guangdong, contract manufacturer
- Fortune Company Ltd. Guangdong, contract manufacturer
- Hengshui Tianjian Medical Supplies Co., Ltd. Hebei, contract manufacturer
- Jiangsu Moen Industrial Co., Ltd. Jiangsu
- JSL CAR Accessories Co., Ltd. Shanghai
- Liven Sports MFG. (Xiamen) Co., Ltd. Fujian
- Medex Medical Supplies Ltd. Guangdong, contract manufacturer
- Ningbo Favored Commodity Co., Ltd. Zhejiang
- Ningbo MPF Manufacturing Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Sincerecare Import AND Export Co., Ltd. Zhejiang
- Orthotech Rehabilitation Co., Ltd. Fujian
- Planet (Anhui) International Co., Ltd. Anhui
- Planet(Shanghai) International Co., Ltd. Shanghai
- Shenzhen Weprotex Technology Product Co., Ltd. Guangdong
- Shaoxing Songqiao Textile Co., Ltd. Zhejiang
- Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd. Guangdong
- Taicang Yigao Medical Technology Co., Ltd. Jiangsu
- Wellpower Sporting Goods Co., Ltd. Guangdong, contract manufacturer
- Xiamen Ortocare Sports Health Co., Ltd. Fujian, contract manufacturer
- Xiamen TWE Orthopedics Co., Ltd. Fujian
- Yangzhou Zhilin Sports Items Co., Ltd. Jiangsu
- Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd. Fujian
- Zhangzhou Recaring Medical Instrument Co., Ltd. Fujian
What Is FDA Product Code ILE?
Sling, Arm, Overhead Supported is FDA product code ILE, Class 1, 21 CFR 890.3475.
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.