Fully Automatic Blood Pressure Monitor

K171282 · Andon Health Co, Ltd. · DXN · Jul 27, 2017 · Cardiovascular

Device Facts

• Record ID: K171282
• Device Name: Fully Automatic Blood Pressure Monitor
• Applicant: Andon Health Co, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 27, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

KD-7923 Fully Automatic Electronic Blood Pressure 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 14cm-25cm

Device Story

The KD-7923 is a fully automatic electronic blood pressure monitor. It uses an inflatable wrist cuff to measure blood pressure and pulse rate via a non-invasive oscillometric technique. Designed for use by medical professionals or patients at home. The device processes pressure oscillations detected during cuff deflation to calculate systolic and diastolic blood pressure and pulse rate. Results are displayed to the user to assist in monitoring cardiovascular health. The device is intended for adult individuals with a wrist circumference between 14cm and 25cm.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison to predicate devices.

Technological Characteristics

Noninvasive oscillometric blood pressure monitor; wrist-worn inflatable cuff (14cm-25cm circumference); electronic sensor for pressure detection; battery-powered; standalone operation.

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adults. Intended for use by medical professionals or at home. Cuff circumference: 14cm-25cm.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2017

Andon Health Co., Ltd Liu Yi President No. 3 Jinping Street Ya An Road Nankai District, Tianjin, 300190 CN

Re: K171282

Trade/Device Name: KD-7923 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 27, 2017 Received: May 1, 2017

Dear Liu Yi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.G. Hilleman

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171282

Device Name

KD-7923 Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

KD-7923 Fully Automatic Electronic Blood Pressure 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 14cm-25cm

| Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> <input checked="checked" type="checkbox"/> </div> |
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| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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