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510(k) Data Aggregation
K Number
K112620Device Name
DISITAL BLOOD PRESSURE MONITOR
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2012-08-02
(329 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blood Pressure Monitor DSK-1031 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.
Device Description
Blood Pressure Monitor DSK-1031 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuff that is applicable to arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm) and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.
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K Number
K112690Device Name
BLOOD PRESSURE MONITOR
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2012-02-24
(162 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.
Device Description
Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
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K Number
K112691Device Name
BLOOD PRESSURE MONITOR
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2012-02-24
(162 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blood Pressure Monitor DSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.
The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines display of body movement detection and two memory account to save measurement results.
Device Description
Blood Pressure Monitor DSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuffs, regular size cuff for arm circumference between 8.7 and 12.6 inches (between 220 and 320 mm) and large size cuff for arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm), and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.
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K Number
K093102Device Name
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2010-06-03
(245 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FB-270/DS-270 is a portable blood pressure monitor for non-invasive blood pressure measurement, monitoring intraday variance of blood pressure in daily life. They measure systolic and diastolic blood pressure and heart rate, at set interval within 24/48 hours or manually, and store the data to SD card (memory card). The collected data can ensure the change in the day of the blood pressure in the personal computer using CD-ROM for exclusive setup. Physicians at medical institutions will check the data on personal computer for analysis of hypertensive and hypotensive diseases.
Device Description
Ambulatory Blood Pressure Monitor FB-270/DS-270 measures highest and lowest blood pressure and heart rate, automatically at interval within 24/48 hours or manually, by its measuring algorithm written in SD card (memory card) inserted into FB-270/DS270. The measuring algorithm is written into SD card by personal computer with specific software installed. Physicians at medical institutions will check stored data of intraday blood pressure variance in daily life on personal computer. This device consists of Cuff main unit employing both Riva-Rocci Korotkov method and oscillometric method, and cuff unit. The cuff can be applied to upper arm circumference in range of 9.06 in. to 12.6 in. (230 mm to 320 mm) for Cuff respectively. Microphone detecting Korotkov sound is incorporated into the device. The cuff consists of pressurizing blooder and nylon cover, and the device consists of microcomputer, event switch, pump, electronically controlled exhaust valve, microphone and indicator. Programming to the device, readout of data measured by the device, and analysis of measurement results are executed by personal computer with exclusive analysis software BH-270 installed. Programming to SD card and readout of measured data from SD card are executed by general use memory reader. Physicians can analyze various graphs such as trend graph, distribution map, histogram, correlation diagram displayed on PC.
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K Number
K080177Device Name
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2008-05-09
(106 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WS-1100WS-1100PV system is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults in a homecare environment.
The device features include the display of irregular pulse rhythm detection, the classification display of measured blood pressure values against the guideline by World Health Organization or equivalent guidelines, the personal setting for individual blood pressure target values, the two memory banks to save the measurement results with date and time of measurement and the transferring the saved results to personal computers.
Device Description
Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are measured in the wrist artery using the oscillometric method. WS-1100WS-1100PV is a single-mounted device of the main unit and the cuff unit. ABS and PMMA are used for the outer housing of the main unit and the Lenticular image is printed as the positioning guide to remind the user to take correct posture for blood pressure measurement. The preformed cuff unit, which is applicable to wrist circumference approximately between 4.9 and 8.5 inches (between 125 and 215 mm), includes the inflatable bladder and the nylon shell. The device consists of the microprocessor, the pressure-frequency converter, the operation keys, the pump, the electromagnetic deflation control valve (ECV) and the display. The device is powered by two AAA alkaline batteries. The cuff, wrapped over the user's wrist, is inflated and deflated during the course of a measurement. Circuits within the cuff sense the oscillations in pressure against the cuff produced by the expansion and contraction of the arteries in the wrist in response to each heart beat. The amplitude of each pressure waves is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value.
Measured blood pressure values are classified against the guideline by World Health Organization or equivalent guidelines and the classified levels are displayed in the reading display. The device compares the measured blood pressure value to the individual target value set by the user and flashes the value when it exceeds the target value.
The device also compares the longest and the shortest time intervals of the detected pulse waves to the mean time interval and flashes heart mark to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25 %.
The user of WS-1100/WS-1100PV can choose to save the measurement results in either one of two memory banks, each of which has the capacity for sixty readings, or not to save the results at the end of a measurement. The results are saved along with the date and time of the measurement and the user can review the saved readings. The device also has feature to display the saved readings taken in the morning and the evening separately. The user can also review the saved readings on a personal computer by downloading saved readings using the designated USB cable included in the product package. The application software is downloaded over the internet.
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K Number
K071596Device Name
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2008-02-15
(248 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portable Air Massager putifino AM-7 is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Portable Air Massager putifino AM-7 simulates kneading and stroking of tissues by using an inflatable garment (Cuff).
Device Description
Portable Air Massager putifino AM-7 is a powered inflatable tube massager, which stimulates kneading and stroking of tissues with the hands by pressurizing and depressurizing the massaging garment (cuff) wrapped around the calf. The cotton and velour massaging cuff with inflatable bladder inside is assembled to the controller to facilitate the device's compactness and portability. The device is applicable to calves whose circumferences are between 8.7 to 17.7 inches (22 to 45 cm). With the included attachable extension hook, the applicable range extends to 19.7 inches (50 cm). The device owns three modes of massage pattern and three levels of massage intensity, which are controlled by the microprocessor. Operation of the mode button on the controller during massaging will switch the massage patterns. In MODE 1, massage is given by repetition of pressurization and depressurization of the cuff, where pressurization is set to one pressure level. In MODE 2, massage pattern of MODE 1 is repeated at two pressure levels. In MODE 3, which is intended to temporary increase blood circulation, approximately 10 minutes of massage at low pressure level and approximately 20 minutes of rest are repeated. In MODE 1 and 2, operation of the pressure button on the controller will switch the massage intensities: weak, moderate and hard. The user of the device can confirm both massage mode and level with the illuminated indicator on the controller.
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K Number
K071384Device Name
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2007-10-09
(145 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
Device Description
The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.
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K Number
K061086Device Name
DM-3000 DIGITAL BLOOD PRESSURE MONITOR
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2006-08-10
(114 days)
Product Code
DXN, MNH, MNI
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician.
Device Description
The Model DM-3000 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement of systolic and diastolic blood pressures and pulse rate in adult patients under the supervision of a physician. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes air pumps for automatic cuff inflation, electric valves, button controls, circuitry to detect and process minute pressure oscillations, a bar LCD to display mercury-column-like pressure flow and a segment LCD to display blood pressure and pulse rate as a digital value and operation indications such as inflation, measurement error and battery error. Measurement can be made either automatically, where entire operation including inflation and deflation of the cuff and determination of blood pressures and pulse rate is automatically done, or manually, where only inflation and deflation of the cuff are automatically done but determination of the blood pressures is done by a physician using a stethoscope. The unit saves the last reading in its memory circuit. The system is powered by the AC adaptor or the rechargeable nickel battery.
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K Number
K050697Device Name
MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2005-03-25
(7 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.
Device Description
The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an I.CD display of systolic and diastolic blood pressure readings and pulse rate, a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.
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K Number
K040309Device Name
DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
Manufacturer
NIHON SEIMITSU SOKKI CO., LTD.
Date Cleared
2004-02-24
(15 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
NIHON SEIMITSU SOKKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. age 18 and above. The product is recommended for use by patients capable of understanding written and/or oral directions in a home care environment.
Device Description
The Nissei Model DS-1862 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations; an electromagnetic deflation-rate control valve, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff.
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