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510(k) Data Aggregation
K Number
K092061Device Name
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
Manufacturer
Date Cleared
2010-03-26
(261 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
GENEXEL MEDICAL INSTRUMENT INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.
Device Description
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel of FP-0217 has power button, mode button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate and date. FP-0217 has memory capacity to store the 58 most recent measurement results.
The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
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