The foot shell is not resistant to ultraviolet light (UV). Do not store it under direct sunlight.
19.
DISPOSAL
The foot is made of fiberglass composite material, rubber, Vibram (H2O), metal and plastic (EVAQ8). The foot shell is made of
thermosetting polymer material. The device and its packaging must be disposed of in accordance with local or national
environmental regulations.
20.
DESCRIPTION OF THE SYMBOLS
Manufacturer
Authorized representative
in the European Union
21.
REGULATORY INFORMATION
This product is a CE-marked medical device and is certified as conforming with Regulation (EU) 2017/745.
INSTRUCTIONS FOR USE
Identified risk
Single patient, multiple
use
Page 6 of 6
CE marking and year of
st
1
declaration
IFU-01-101