Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 20

Figure 2.6
Orthotic classification. (Courtesy FDA)
Once again, note the relevant data: it is Class I and 510(k) exempt. However, the device is
GMP exempt . The value of this piece of information will be explored in more detail later. The
classification would be:
Device: Shoe, Cast
Class I. Product Code: HPG. Regulation No.: 890.3025.