AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K132627 · Honsun (Nantong) Co., Ltd. · DXN · Oct 23, 2013 · Cardiovascular

Device Facts

• Record ID: K132627
• Device Name: AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Honsun (Nantong) Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 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 arm.

Device Story

The Fully Automatic Blood Pressure Monitor (Models LD-535 & LD-539) is an oscillometric device for non-invasive blood pressure and pulse rate measurement. It utilizes an inflatable arm cuff to detect arterial pressure oscillations. The device is intended for over-the-counter use by adults. It processes pressure signals to calculate systolic and diastolic blood pressure and pulse rate, displaying results on an integrated screen. It provides users with a convenient method for monitoring cardiovascular metrics at home, facilitating self-management of blood pressure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Oscillometric measurement principle; non-invasive inflatable arm cuff; digital display; standalone operation; battery-powered.

Indications for Use

Indicated for adult individuals for non-invasive measurement of systolic and diastolic blood pressure and pulse rate using an arm-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.

Predicate Devices

• K132627 (Note: Document identifies subject device as K132627; no specific predicate device names/numbers provided in text)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 23, 2013

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO60-G609 Silver Spring, MI) 20993-0002

Honsun (Nantong) Co., Ltd. Selina Qian No.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, Jiangsu, 226009 CH

Re: K132627

> Trade/Device Name: Automatic digital 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: October 10, 2013 Received: October 15, 2013

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, 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Selina Qian

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.goy/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Owen P. Faris -S

for

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

Enclosure

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## INDICATION FOR USE

Page 1 _ of __ 1

510(k) Number (if known): ___K132627

Device Name: Fully Automatic Blood Pressure Monitor

Model: LD-535 & LD-539

Indication for Use:

The Fully Automatic Blood Pressure Monitor LD-535 & LD-539 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 arm.

| Prescription Use | ____________________ |
|----------------------------|-----------------------|
| (Per 21 CFR 801 Subpart D) | OR |
| Over-The Counter Use | X____________________ |
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2013.10.23
10:26:47 -04'00'

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