BLOOD PRESSURE METER, MODEL CH-4532

K093931 · Citizen Systems Japan Co., Ltd. · DXN · Jun 10, 2010 · Cardiovascular

Device Facts

• Record ID: K093931
• Device Name: BLOOD PRESSURE METER, MODEL CH-4532
• Applicant: Citizen Systems Japan Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Device Story

Model CH-4532 is an automated, non-invasive blood pressure monitor. It utilizes the oscillometric method to measure systolic and diastolic blood pressure and pulse rate. Designed for home use, the device is operated by the user for personal health monitoring without requiring physician supervision. The device captures pressure oscillations via an arm cuff, processes the signal to determine blood pressure values, and displays the results on an integrated screen. This allows users to track their cardiovascular health metrics independently.

Clinical Evidence

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

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Class II device (Product Code: DXN). Operates via automated cuff inflation/deflation and pressure sensing. Intended for home use.

Indications for Use

Indicated for individuals seeking to monitor personal blood pressure and pulse at home. Intended for over-the-counter use.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 0 2010

Citizen Systems Japan Co., Ltd. c/o Mr. Nathan A. Beaver Foley & Lardner LLP 3000 K Street NW, Suite 600 Washington, DC 20007

Re: K093931

> Trade/Device Name: Model CH-4532 Blood Pressure Meter Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 11, 2010 Received: May 11, 2010

Dear Mr. Beaver:

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 - Mr. Nathan A. Beaver

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/Resourcesfor You/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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K093931

Image /page/2/Picture/1 description: The image contains the word "CITIZEN" in large, bold, black letters. Below "CITIZEN" is the phrase "Micro HumanTech" in a smaller font, also in black. To the right of the word "CITIZEN" is a handwritten fraction, which appears to be "1/1".

CITIZEN SYSTEMS JAPAN CO., LTD.

6-1-12, Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, Japan Tel : [phone] Fax : [phone]

Date : November 30, 2009

## Indications for Use

510(k) Number (if known):

Device Name: Model CH-4532 Blood Pressure Meter

Indications For Use: Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_____________X

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