DIGITAL BLOOD PRESSURE MONITOR

K092719 · Shanghai Little Doctor Electronic Co., Ltd. · DXN · Sep 18, 2009 · Cardiovascular

Device Facts

• Record ID: K092719
• Device Name: DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Shanghai Little Doctor Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Shanghai Little Doctor Automatic Digital Blood Pressure Monitor LD6&LD7 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 upper arm. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal once the irregular heartbeat is detected.

Device Story

Automatic Digital Blood Pressure Monitor (Models LD6, LD7) measures systolic/diastolic blood pressure and pulse rate. Device uses oscillometric method via inflatable upper arm cuff. Operates as over-the-counter device for adult self-use or clinical setting. Input: pressure oscillations from cuff. Processing: internal firmware detects pressure changes and identifies irregular heartbeats. Output: digital display of blood pressure values and pulse rate; visual warning signal for irregular heartbeat. Assists users in monitoring cardiovascular health status.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Includes inflatable upper arm cuff, pressure sensor, and digital display. Powered by internal battery/power source. Firmware-based processing for pressure oscillation analysis and irregular heartbeat detection.

Indications for Use

Indicated for adult individuals for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm cuff. Includes irregular heartbeat detection and warning signal.

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 Room W-O66-0609 Silver Spring, MD 20993-0002

Shanghai Little Doctor Electronic Co., Ltd. c/o Mr. Marc M. Mouser Manager & FDA Office Coordinator, Program Reviewer Underwriters Laboratory, Inc. 2600 NW Lake Road Camas, WA 98607

Re: K092719

> Trade/Device Name: Automatic Digital Blood Pressure Monitor, Model: LD6 & LD7 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 17, 2009 Received: September 3, 2009

SEP 1 8 2009

## Dear Mr. Mouser:

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.

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.

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Page 2 - Mr. Marc M. Mouser

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 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/ucm115809.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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Page 1 of 1

510(k) Number (if known):

K092719

Device Name: Automatic Digital Blood Pressure Monitor Model: LD6&LD7

# Indication for Use:

The Shanghai Little Doctor Automatic Digital Blood Pressure Monitor LD6&LD7 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 upper arm.

The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal once the irregular heartbeat is detected.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use ×

(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)

ivision Sign-Off) ivision of Cardiovascular Devices

510(k) Number K04

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