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510(k) Data Aggregation
K Number
K122443Device Name
UFIT TEN-10
Manufacturer
Date Cleared
2012-11-20
(102 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
BIOSIGN TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services is a non-invasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate. It is intended for patient use at home and by healthcare professionals in their respective practice.
The device is intended for use by adults 18 years or older. The cuff is to be used for wrist sizes from 13.5 cm to 23 cm (5.3 in to 9.1 in).
Device Description
UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-23cm.
UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric method and pressure sensor technology. It calculates the systolic and diastolic blood pressure. UFIT® TEN-10 "Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services" achieves its function by connecting the device to a Personal Computer via USB connection. Furthermore the device does not contain an LCD or other display components, so it is necessary for the device to connect to a Personal Computer containing a support software to constitute a complete blood pressure measurement system.
When a reading is taken by the device through the software, it is sent through the Internet to servers that perform the analysis of the reading and the result is returned through the Internet to the end user - all by means of Cloud Computing. This provides secure accounts for the users to submit their data so that they can monitor their results and progress.
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