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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.
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Inclusion Criteria:
Exclusion Criteria:
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To include the maximum types of patients, the selection was opened to all the general public who could use the multifunction Keito in a public site, where is is intended to be placed. The test was carried out following the user's manual rules about who can use the device.
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| Name | Affiliation | Role |
|---|---|---|
| Angel P Ferre, Telecommunications Engineer | Aguiflai Iberica, S.L. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aguiflai Iberica, s.l | Vilassar de Mar | Barcelona | 08340 | Spain |
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