Orthosis, Limb, for Back Pain
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Hebei. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Dongguan LEE-MAT Sports Technology Co., Ltd. Guangdong
- Hebei Leamai Medical Instrument Co., Ltd. Hebei
- Wellpower Sporting Goods Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
How Is PMV Classified?
Orthosis, Limb, For Back Pain is FDA product code PMV, Class 1, 21 CFR 890.3475.
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. It is also exempt from most of the quality system regulation.
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