Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
The researchers believe that the multifunction Keito devices shares with TANITA TBF-300
 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are
 not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate
 gives results as similar as the multifunction keito does.
177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the
 devices under test, the observers measured the weight and height of each volunteer prior to
 measure the body fat. This was done to configure a preliminary idea about the body
 composition of the subject.

 Both devices are designed by the same technology to emit a low current through the body, and
 finally make a measurement of the impedance found between the body contact points. We
 expected the results to be very similar.
Inclusion Criteria:

 -  All population who meet with the requirements described on the user's manual.

 Exclusion Criteria:

 -  Pregnant women.

 -  Individuals who have a pacemaker or any other internal medical device.

 -  Population whose weight is under 15 Kg and less than 135 cm tall.