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510(k) Data Aggregation
K Number
K212312Device Name
RA-T59 Wrist blood pressure monitor
Manufacturer
Date Cleared
2022-01-27
(188 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
LotusNine Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a digital monitor for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 inches to 7 1/4 inches (12.8 cm to 18.5 cm).
Device Description
RA-T59 Wrist blood pressure monitor is designed to measure the blood pressure and pulse rate of adults within the range of the designated wrist cuff (12.8 to 18.5 cm). RA-T59 Wrist blood pressure monitor is based on an oscillometric method to measure blood pressure and pulse rate from wrist. The device uses automatic inflation mode. It starts to inflate from 0 mmHg and automatically stops the motor after 25 seconds and quickly deflates, with a steady inflation speed detecting the measurement during inflation. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The signal from the electronic pressure sensor is conditioned with a circuit before data conversion by an analog-to-digital converter (ADC). The systolic pressure, diastolic pressure, and pulse rate are then calculated in the digital domain. The resulting systolic, diastolic, and pulse-rate measurements are displayed on a LCD and stored in the device's memory.
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