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510(k) Data Aggregation
K Number
K163276Device Name
Fully Automatic Electronic Blood Pressure Monitor
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2017-05-11
(171 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor 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 14cm-25cm.
Device Description
KD-721 and KD-723 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
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K Number
K162668Device Name
Fully Automatic Electronic Blood Pressure Monitor
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2017-02-14
(141 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KD-926 Fully Automatic Electronic Blood Pressure Monitor 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 upper arm. The cuff circumference is limited to 22cm-48cm.
Device Description
KD-926 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
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K Number
K162144Device Name
iHealth Wireless Blood Pressure Monitor
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2017-02-01
(184 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)
Device Description
iHealth BPM1 Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.
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K Number
K150833Device Name
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2015-12-04
(249 days)
Product Code
NBW, CGA, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Alian Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth Align Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Align Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5 wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth BG5 wireless Smart Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth BG5 wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The AGS-1000I test strips are for use with the iHealth BG5 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh. The iHealth BG5L wireless Smart Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth BG5L wireless Smart Gluco-Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth BG5L wireless Smart Gluco-Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The AGS-1000I test strips are for use with the iHealth BG5L meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
Device Description
The iHealth Align Gluco-Monitoring System consists of a blood glucose meter, test strips, iHealth Gluco-Smart App, sterile lancets, lancing device and AGS-1000I Control Solutions (Level I. Level II and Level III). The iHealth Align Gluco-Monitoring System cannot display test results and must be used with an iPhone or iPod touch via an 3.5 mm auxiliary jack.
The iHealth BG5 wireless Smart and iHealth BG5L wireless Smart Gluco-Monitoring Systems consist of the BG5 and BG5L wireless Smart blood glucose meters, respectively, AGS-10001 Test Strips , sterile lancets, lancing device and the iHealth control solutions control solutions. (Control solutions provided are for Level 1, II, and III). iHealth BG5L uses Bluetooth 4.0 wireless radio technology; while iHealth BG5 uses Bluetooth 3.0 wireless radio technology. The iHealth BG5 and BG5L meters can display the test results and the test results can also be transmitted to an iPhone, iPod touch or iPad through blue tooth.
iHealth Gluco-Smart App is iOS- based software for use with the iHealth Align Glucose meter (BG1), iHealth BG5 meter, and iHealth BG5L meter. When used with these meters, iHealth Gluco-Smart App acts as a display and allows command and control of the meter. The App can transfer data from the device's memory, manage, and share the data.
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K Number
K152003Device Name
iHealth BP3L Wireless Blood Pressure Monitor
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2015-09-24
(66 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iHealth BP3L Wireless Blood Pressure Monitor 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 upper arm. The cuff circumference is limited to 22cm-48cm.
Device Description
iHealth BP3L Wireless Blood Pressure Monitors are designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices.
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K Number
K152379Device Name
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2015-09-23
(33 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic 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-22cm.
Device Description
iHealth View BP7S Wireless Blood Pressure Monitors are designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices.
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K Number
K150043Device Name
Transcutaneous Electrical Nerve Stimulators (TENS)
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2015-08-14
(217 days)
Product Code
NUH, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Device Description
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
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K Number
K131111Device Name
IHEALTH FINGERTIP PULSE OXIMETER
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2013-09-11
(145 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PO3M Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery. anesthesia, intensive care, etc).
Device Description
Our device PO3M Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.
The power source is Lithium-ion battery.
More over, the PO3M can transmit the measurement data to the iPhone, iPod Touch or iPad by wireless transmission.
The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.
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K Number
K120672Device Name
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2012-06-01
(88 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KD-936 Fully Automatic Wireless Blood Pressure Monitor 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 upper arm. The cuff circumference is limited to 22cm-48cm.
Device Description
KD-936 Fully Automatic Wireless Blood Pressure Monitor 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-936 Fully Automatic Wireless Blood Pressure Monitor is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results.
KD-936 Fully Automatic Wireless Blood Pressure Monitor achieves its function by integrate the device with an iPhone, ipod or ipad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth,
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K Number
K111826Device Name
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Manufacturer
ANDON HEALTH CO.,LTD
Date Cleared
2011-12-09
(164 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ANDON HEALTH CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
Device Description
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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 upper arm. The cuff circumference is limited to 22cm-48cm.
They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.
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