Apos 4
30 catalogue numbers from APOS 4 BLACK VELCRO HIGH CUT KNIT 35, listed by Apos Medical Assets Ltd, Israel, under Shoe With Adjustable Sole Units. 2 manufacturers in China are registered for this product code.
Shoe With Adjustable Sole Units
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Dongguan Redthera Technology Co., Ltd. Guangdong
- Wenzhou First Light Industry Co., Ltd. Zhejiang, contract manufacturer
What Is It?
Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb
How Is QDT Classified?
Shoe With Adjustable Sole Units is FDA product code QDT, 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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