CE marking only applies to products covered by EU regulations—not all products should carry CE. For the US market, whether a support product is regulated as a medical device depends on its intended use and the claims made about it. Our group company, Hangzhou Zhongzhi Industry Co., Ltd., holds FDA establishment registration and device listing for our main support categories (documents on request). We recommend avoiding medical claims (“treat/cure”) and using “support/stability/comfort” instead.
We assist with compliance documentation, but final classification must be confirmed by your compliance team.