Graduated Compression Hosiery

Compression hosiery marketed with specific therapeutic or medical claims — such as treatment of chronic venous insufficiency or post-surgical edema — may be regulated as a medical device by FDA, triggering admissibility review. Products sold purely as wellness or comfort items with no medical claims are less likely to require device clearance, but the line is fact-specific. Importers should consult a licensed customs broker and, where appropriate, FDA's device classification database before importing.

The SITC heading itself does not subdivide by mmHg rating, but the pressure class is commercially critical: it determines whether the product is positioned as a medical device, a prescription item, or an over-the-counter wellness product. That positioning in turn affects FDA admissibility requirements and how the product is labeled and marketed in the US market.