FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET

K043437 · Health & Life Co., Ltd. · DXN · Jan 12, 2005 · Cardiovascular

Device Facts

• Record ID: K043437
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional). The intended use of this over-the counter device is for age 16 and above.

Device Story

The HL168ET is an over-the-counter, fully automatic non-invasive blood pressure (NIBP) monitor. It utilizes the oscillometric method to measure systolic and diastolic blood pressure and heart rate. The device is intended for self-use by individuals aged 16 and older. Input is obtained via an inflatable cuff; the device processes pressure oscillations to calculate hemodynamic parameters. Outputs are displayed on an integrated LCD panel and can be announced via an optional English voice feature. The device provides users with immediate physiological data to monitor blood pressure and heart rate, facilitating home-based health tracking.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and the established oscillometric measurement method.

Technological Characteristics

Oscillometric measurement principle; automatic inflation/deflation; LCD display; optional voice output; standalone battery-operated device.

Indications for Use

Indicated for individuals age 16 and older for the automatic measurement of systolic and diastolic blood pressure and heart rate using the oscillometric method.

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

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JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Health & Life Co., Ltd. c/o Mr. Paul Hung Manager 9F, No. 186, Jian-Yi Road Chung Ho City, 235 Taiwan, Province of China

Re: K043437

K045437
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor HL168ET Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: December 06, 2004 Received: December 13, 2004

Dear Mr. Hung:

We have reviewed your Section 510(k) premarket notification of intent to market the device t We nave reviewed your Security promainer is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interestate referenced above and nave determined the arrood predicate devices marketed in interstate for use stated in the enclosure) to tegally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of any lie devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosment Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the good if the gold be and general controls provisions of the fields of the eliment against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Code of I sacra. Its gening your device in the Federal Register.

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Page 2 – Mr. Paul Hung

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); 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,

B. Benima fer

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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## 510(k) Number (if known) : K ~ 043437

Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor

Trade Name : HL168ET

## Indications For Use

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional).

The intended use of this over-the counter device is for age 16 and above.

i

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription USE (Per 21 CFR 801.109) | OR | Over-The-Counter Use( √ ) (Optional Format 1-2) |
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ardiovascular Devices

K043437

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