WRIST AUTOMATIC BLOOD PRESSURE MONITOR

K131463 · Honsun (Nantong) Co., Ltd. · DXN · Jul 8, 2013 · Cardiovascular

Device Facts

• Record ID: K131463
• Device Name: WRIST AUTOMATIC BLOOD PRESSURE MONITOR
• Applicant: Honsun (Nantong) Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Wrist Automatic Blood Pressure Monitor LD-737 is device 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 wrist.

Device Story

The Wrist Automatic Blood Pressure Monitor (Model LD-737) is an electronic, non-invasive device designed for over-the-counter use by adults to measure systolic/diastolic blood pressure and pulse rate. The device utilizes an inflatable cuff wrapped around the wrist to detect arterial oscillations. An internal microprocessor processes these pressure signals to calculate blood pressure and heart rate, which are then displayed on an integrated screen. The device is intended for home use, allowing patients to monitor their cardiovascular metrics independently. The output provides immediate feedback to the user, facilitating self-management of blood pressure and assisting in clinical decision-making by providing longitudinal data for healthcare providers.

Clinical Evidence

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

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Features an inflatable wrist cuff, electronic pressure sensor, and microprocessor-based signal processing. Battery-powered. Standalone device with integrated digital display. Designed for adult use.

Indications for Use

Indicated for adult individuals to measure systolic and diastolic blood pressure and pulse rate via non-invasive wrist cuff.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 8, 2013

Honsun (Nantong) Co., Ltd c/o Ms. Selina Qian Regulatory Affairs Manager No8 Tongxing Road Nantong Economic and Technology Zone Nantong, Jiangsu, 226009 CH

Re: K131463

> Trade/Device Name: Wrist Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 19, 2013 Received: May 21, 2013

Dear Ms. 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, 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

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## Page 2 - Ms. Selina Qian

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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Owen P. Faris -S

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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### K131463

### INDICATIONS FOR USE

Page __ of _l

510(k) Number (if known): __ K131463

Device Name: Wrist Automatic Blood Pressure Monitor Model: LD-737

Indication for Use:

The Wrist Automatic Blood Pressure Monitor LD-737 is device 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 wrist.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

Over-The Counter Use _X (21 CFR 807 Subpart C) OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.07.08
16:30:29 -04'00'