Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U

K170454 · Honsun (Nantong) Co., Ltd. · DXN · Oct 25, 2017 · Cardiovascular

Device Facts

• Record ID: K170454
• Device Name: Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
• Applicant: Honsun (Nantong) Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Device Story

Scian Automatic Digital Blood Pressure Monitor (Models LD-562U, LD-588U, LD-533U) is an over-the-counter, non-invasive device for adult use. It utilizes an inflatable upper arm cuff to measure systolic/diastolic blood pressure and pulse rate. The device processes pressure oscillations to calculate hemodynamic parameters and detects irregular heartbeats, providing a warning signal to the user. It is intended for home or clinical use by the patient or healthcare provider. Output is displayed on the device screen, allowing users to monitor blood pressure trends and identify potential cardiac irregularities, facilitating informed health management.

Clinical Evidence

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

Technological Characteristics

Non-invasive oscillometric blood pressure monitor; upper arm cuff; digital display; electronic pressure sensor; irregular heartbeat detection algorithm; battery-powered; standalone operation.

Indications for Use

Indicated for adult individuals to measure systolic/diastolic blood pressure and pulse rate via non-invasive upper arm cuff. Detects irregular heartbeats and provides warning signals.

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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October 25, 2017

Honsun(nantong) Co., Ltd. Selina Oian QA Manager No. 8, Tongxing Road, Nantong Economic & Technology Development Zone Nantong, 226009 CN

Re: K170454

Trade/Device Name: Scian Automatic Blood Pressure Monitor, Models LD-562U, LD-588U & LD-5330 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 26, 2017 Received: September 26, 2017

Dear Selina Qian:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Willemsen

for Bram D. Zuckerman, M.D. 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) K170454

Device Name

Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U

Indications for Use (Describe)

Indication for Use:

The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.

Type of Use (Select one or both, as applicable)

| | Research Use (Part 21 CFR 201.Subject to) |
|--|------------------------------------------------------|
| | <i>In-Vitro</i> Contract Use (21 CFR 201.Subject to) |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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