WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES

K092558 · Harvard Medical Devices , Ltd. · DXN · Mar 17, 2010 · Cardiovascular

Device Facts

• Record ID: K092558
• Device Name: WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
• Applicant: Harvard Medical Devices , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic 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. The theoretical range of cuff circumference is limited to 14-19.5cm.

Device Story

Wrist-worn non-invasive blood pressure monitor; utilizes inflatable cuff wrapped around wrist; measures systolic/diastolic blood pressure and pulse rate; intended for home use by adult individuals; operates via oscillometric technique; provides digital display of blood pressure and pulse readings; assists users in monitoring cardiovascular health status.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor; wrist-worn; inflatable cuff (14-19.5cm circumference); digital display; battery-powered; standalone device.

Indications for Use

Indicated for adult individuals for non-invasive measurement of systolic and diastolic blood pressure and pulse rate using an inflatable wrist cuff (circumference 14-19.5cm) in a home setting.

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

Harvard Medical Devices Ltd. c/o Mr. Martin Ma Unit 1301-2, 13th Floor, Railway Plaza 39 Chatam Road South Tsimshatsui, Kowloon

Re: K092558

Hong Kong

Trade Name: Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Monitors Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: February 26, 2010

Dear Mr. Ma:

This letter corrects our substantially equivalent letter of March 17, 2010.

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.

## APR 2 9 2010

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Page 2 - Mr. Martin Ma

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.

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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## Indication for Use

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ K092558

Device Name:

Wrist Type Blood Pressure Monitor, HMBPM-005/Kinetik Branded BPM2 Series

Indication For Use

Wrist Type Blood Pressure Monitor is for use at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic 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. The theoretical range of cuff circumference is limited to 14-19.5cm.

Prescription Use_

AND/OR Over-The-Counter Use_ YES

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.A.

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vision of Car

(k) Number K092555