Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009

Aguiflai Iberica

Status: Completed

Conditions: Body Fat

Study type: Observational

Funder types: Industry

Identifiers

NCT01360619

K8-FAT-05062007

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 82 years old

Volunteers: Accepts Healthy Volunteers

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.