What Incrediwear can say regarding status of its products with the FDA

• In accordance with FDA specifications, Incrediwear’s products are Class I medical devices
• Incrediwear’s products are FDA registered and listed
• FDA requires that all Incrediwear product claims are substantiated in accordance with their regulations
• Incrediwear’s products are compliant with all applicable FDA regulations

What Incrediwear cannot say regarding status of its products with the FDA

• Class I medical devices are 510K and GMP (good manufacturing practices) exempt, therefore Incrediwear cannot say its products have “510K Clearance” from the FDA