DIGITAL BLOOD PRESSURE MONITOR

K123600 · Little Doctor Electronic (Nantong)Co.,Ltd · DXN · May 3, 2013 · Cardiovascular

Device Facts

• Record ID: K123600
• Device Name: DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Little Doctor Electronic (Nantong)Co.,Ltd
• Product Code: DXN · Cardiovascular
• Decision Date: May 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Electronic Blood Pressure Monitor LD-568, LD-520, LD-522, LD-587 & LD-528 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 device is an automatic digital blood pressure monitor (Models LD-568, LD-520, LD-522, LD-587, LD-528) designed for non-invasive measurement of systolic and diastolic blood pressure and pulse rate. It utilizes an inflatable cuff wrapped around the user's arm to capture oscillometric signals. The device processes these signals to calculate blood pressure and pulse rate, displaying the results on an integrated screen. It is intended for use by adults in a home or clinical setting. The output provides users with immediate physiological data to monitor cardiovascular health.

Clinical Evidence

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

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Device consists of an electronic monitor and an inflatable arm cuff. Operates via automated inflation/deflation cycles to detect pressure oscillations. Class II device (21 CFR 870.1130, Product Code DXN).

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adult individuals 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.

Submission Summary (Full Text)

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Public Health Service

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

May 3, 2013

Little Doctor Electronics (Nantong) Co., Ltd. c/o Ms. Selina Qian No. 8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, Jiangsu CHINA 226009

Re: K123600

> Trade/Device Names: Automatic Digital Blood Pressure Monitor, Model LD-568, LD-520, LD-522, LD-587 & LD-528 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 19, 2013 Received: April 3, 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 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 - Ms. Selina Oian

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/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/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

Owen-P.Faris -S

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

Enclosure

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## INDICATIONS FOR USE

Page ー of

510(k) Number (if known): __ K123600

Electronic Blood Pressure Monitor Device Name: Model: LD-568, LD-520, LD-522, LD-587 & LD-528

Indication for Use:

The Electronic Blood Pressure Monitor LD-568, LD-520, LD-522, LD-587 & LD-528 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 _________________________________________________________________________________________________________________________________________________________ (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)

Owen P. Faris -S
2013.05.03 12:52:51
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