iFIT Prosthetics

iFIT Prosthetics specializes in immediate-fit, fully adjustable prosthetic devices. Their primary focus is on transtibial (below-the-knee) prosthetic solutions, including customizable sockets designed for durability and comfort. These products are tailored to enhance mobility and quality of life for individuals with limb loss.

iFIT Prosthetics is based in the United States. As a manufacturer, it operates within the regulatory framework of the country, ensuring its devices meet applicable standards for prosthetic limb products.

iFIT Prosthetics’ devices are listed in the EU’s eudamed registry. This platform serves as a central database for medical device information within the European Union, allowing stakeholders to verify and track authorized products.

iFIT Prosthetics’ devices fall under Class I regulatory classification. This classification applies to low-risk medical devices, including certain prosthetic limbs, where the risk to patients is minimal. The classification determines the regulatory pathway and requirements for authorization.