M-Brace Air
Made of an elastic fabric, the CLAVICLE SUPPORT is comfortable and easy to put on. It is composed of two bands to be worn on the right and left shoulder, crossed behind the back and then…
Orthosis, Truncal, for Dysmenorrhea
Who Makes This Device Type in China?
8 manufacturers in China hold an FDA registration for this device type, concentrated in Fujian, Shanghai and Anhui, and 1 other province.
- Abletech Orthopedics Corporation Taiwan, contract manufacturer
- AID United International Co., Limited Shanghai
- Liven Sports MFG. (Xiamen) Co., Ltd. Fujian
- Orthotech Rehabilitation Co., Ltd. Fujian
- Planet (Anhui) International Co., Ltd. Anhui
- Planet(Shanghai) International Co., Ltd. Shanghai
- Zhangpu Ortholife Rehabilitation Co., Ltd. Fujian
- Zhangzhou Recaring Medical Instrument Co., Ltd. Fujian
What Is It?
A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.
How Is NJB Classified?
Orthosis, Truncal, For Dysmenorrhea is FDA product code NJB, Class 1, 21 CFR 890.3490.
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.
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