What does FDA cleared even mean?
I see so many products claiming to be FDA cleared, FDA registered, FDA approved?….it’s maddening!!
Trust me, we understand the confusion. The jargon and terminology for anybody who is not familiar with the process is very confusing.
Technically every medical device/product is supposed to “register” with the FDA, so advertising FDA registered is frowned upon by the FDA because it implies something more than what you are legally bound to do anyhow.
Our latest product, EZ-Bak® Massager is a non-powered massager for home use and only requires FDA Registration.
FDA approved is reserved for medical devices/products that are life threatening in nature.
This is one of the highest forms of FDA certifications and requires significant testing, studies and monitoring before the FDA will allow a product/device to claim FDA approved status and subsequently be marketed in the USA.
FDA cleared is for products/devices that are non-life threatening and in a lower classification than FDA approved products.
Lo-Bak TRAX, as the FDA stated, “introduces a different fundamental scientific technology to Non-Powered Orthopedic Traction”.
Lo-Bak TRAX submitted a 510(k) application and was cleared by the FDA on August 2, 2011. Lo-Bak TRAX was given the “clearance” to be marketed in the USA and was assigned the FDA 510(k) clearance # K110858.
You can review Lo-Bak TRAX’s status on the FDA website by searching it’s name or FDA clearance # K110858.