MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A

K030561 · Mytech Technology Co., Ltd. · DXN · May 9, 2003 · Cardiovascular

Device Facts

• Record ID: K030561
• Device Name: MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
• Applicant: Mytech Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".

Device Story

Noninvasive blood pressure monitor (wrist-cuff style) for home use; measures systolic/diastolic blood pressure and pulse rate in adults. Device uses inflatable cuff to occlude/sense arterial pressure oscillations; processes signals to derive blood pressure values; displays results to user. Enables self-monitoring of cardiovascular health; assists in tracking blood pressure trends.

Technological Characteristics

Noninvasive blood pressure measurement system; wrist-worn inflatable cuff; electronic sensing of pulse and pressure oscillations; Class II device (Product Code DXN).

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adults over age 18. For home use. Cuff circumference 5.25"-7.75".

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 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Dr. Ke-Min Jen Roc Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, Roc

Re: K030561

Trade Name: Mytech/Happy Life Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 12, 2003 Received: February 21, 2003

Dear Dr. Jen:

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 such 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

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Page 2 - Dr. Ke-Min Jen

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

KOCATLM

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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## MYTECH TECHNOLOGY CO., LTD.

5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: [phone] Fax: [phone] Email: [e-mail]

Applicant: Mytech Technology Co., Ltd..

510(k) Number ( if known):

Device Name: MYTECH / HAPPY LIFE / BLOOD PRESSURE MONITOR, HPL-100, HPL-100A

● Indications for use:

The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult inclividual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" - 7.75".

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| Concurrence of CDRH, office of Device Evaluation (ODE) |
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| (Division Sign-Off) |
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| Division of Cardiovascular Devices |

| 510(k) Number | K030561 |
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| Prescription Use | OR | Over-The-Counter-Use |
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| ( Per 21 CFR 801.109 ) | | ( Optional Format 1-2-96 ) |