7. Symbols Used
7-1 UDI Label (Packing Box)
Legal manufacturer
Medical device
MD
SN
Serial number
EC REP
Authorized representative for EU countries
The maximum and minimum temperatures for
+50°C
122°F
storing, transporting, and using the product.
-20°C
-4°F
Declaration of conformity according to the
European Regulation 2017/745
Single patient multiple use
7-2 Body Mass Limit Label (Knee Joint Body)
MAX. WEIGHT
~K3 (M0B3): 125kg
K4 (M0B4):100kg
■
K Level (MOB)
K1 Level (MOB1): User can move to a bed or
chair, and can walk on a flat surface indoors at a
constant speed.
K2 Level (MOB2): User can handle small
environmental barriers such as curbs, steps, or
irregular ground both indoors and around the home.
K3 Level (MOB3): User can handle most
environmental barriers and can walk at different
speeds. In addition to simple walking, he/she can
do light work and exercise as well.
K4 Level (MOB4): User has physical abilities
higher than basic walking; children, athletes, etc.
7-3 Product Type Label (Knee Joint Body)
A
N0.
B
Nabtesco
MADE IN JAPAN
Declaration of conformity according to the
European Regulation 2017/745
Made date
Item number
REF
Global Trade
Item Number
Body mass limit not
to be exceeded.
A Product type
B Serial number
EN – 15
31