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510(k) Data Aggregation
K Number
K103058Device Name
MULTIFUNCTION KEITO
Manufacturer
Date Cleared
2011-11-10
(392 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
AGUIFLAI IBERICA S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, estimation of body fat index, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.
Device Description
The Multifunction Keito K6, K7 & K8 are intended for public use to measure height, weight, systolic and diastolic blood pressures, to calculate pulse rate and body mass, and to estimate the percentage of body fat by using a non-invasive bio impedance analyzer. The devices have 2 coin entries allowing the selection of two operation modes: partial or total cycle of measurements. Partial cycle measures weight, height, and estimation of body fat. Total cycle measures weight, height, blood pressure, pulse rate, and estimation of body fat.
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