Kinetic's Life Support Policy is stated below:
KINETIC'S PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL
COMPONENTS IN LIFE SUPPORT DEVICES OR SYSTEMS WITHOUT THE
EXPRESS WRITTEN APPROVAL OF THE CEO OF KINETIC TECHNOLOGIES.
As used herein:

a. Life support devices or systems are devices or systems which (1) are intended
for surgical implant into the body, or (2) support or sustain life and whose failure
to perform when properly used in accordance with instructions for use provided
in the labeling can be reasonably expected to result in a significant injury to the
user.

b. A critical component is any component in a life support device or system whose
failure to perform can be reasonably expected to cause the failure of the life
support device or system or to affect its safety or effectiveness.