FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888

K042265 · Health & Life Co., Ltd. · DXN · Aug 31, 2004 · Cardiovascular

Device Facts

• Record ID: K042265
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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. The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ) .

Device Story

Full Automatic (NIBP) Blood Pressure Monitor (Model HL888) is an over-the-counter device for adult use. It utilizes the oscillometric method to measure systolic and diastolic blood pressure and heart rate. The device features an arm cuff for patients with circumferences between 24cm and 44cm. Inputs are pressure oscillations detected during cuff deflation; the device processes these signals to calculate blood pressure and heart rate values. Outputs are displayed on an integrated LCD panel. The device is intended for home use by patients to monitor their own vital signs, assisting in personal health management.

Clinical Evidence

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

Technological Characteristics

Noninvasive blood pressure monitor using the oscillometric measurement principle. Features an integrated LCD display. Designed for adult arm circumferences of 24cm-44cm. Operates as a standalone, over-the-counter device.

Indications for Use

Indicated for adult patients with arm circumference 24cm-44cm for automatic measurement of systolic/diastolic blood pressure and heart rate.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Health & Life Co., Ltd. c/o Dr. Tzu-Wei Li Industrial Technology Research Institute Center for Measurement Standards Bldg. 16, 321 Kuang Fu Rd., Sec.2 Hsinchu, Taiwan 30042 CHINA

Re: K042265

K042203
Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL888 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 17, 2004 Received: August 23, 2004

Dear Dr. Li :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 310(x) pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosule) to regally management date of the Medical Device American Frank Food. Drya commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accerdance was a proval approval application (PMA). and Cosmetic Ac. (Act) that to not require appent of the general controls provisions of the Act. The You may, utcrefore, manect the do rece, belyer to the more of annual registration, listing of general controls provisions of the recess 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 If your device is classified (500 a0070) into existing major regulations affecting your device can may be subject to such adultional controller Entrologically on 898. In addition, FDA may oc found in the Court concerning your device in the Federal Register.

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Page 2 - Dr. Tzu-Wei Li

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA s issuation of a but complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that FDA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations damandverse of of not limited to: registration and listing (21 comply with an the Act 3 requirements, news 801);
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice destractively at any CFK Part 807); labeling (21 CFR Part 801); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 CFR 1800 form in the quality systems (QB) regardin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of Persons of Persons on your Section 510(k)
This letter will allow you to begin marketing your device as described in your devi I his letter will anow you to ocgain mailioting your antial equivalence of your device to a legally premarket notheation. The PDA midning of bassification 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 If you desire specific advice for your as not 100 % 2008 . Also, please note the regulation entitled, and Comaci the Office of Compilance an (est notification" (21CFR Part 807.97). You may obtain Misoranding of Icrerchee to promation on your responsibilities under the Act from the Division of Small other gelleral informational 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,

Neil R.P. Ogden

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) :

: Full Automatic (NIBP) Elood Pressure Monitor Device Name : HL888 Trade Name

## 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.

The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm -- 44cm (approx. 9.4" to 17.5" ) .

| Prescription Use ( )<br>(per 21 CFR 801.109) | or | Over-The-Counter Use ( <b>V</b> )<br>(Optional format 1-2) |
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(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K042265 |
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Concurrence of CDRH, Office of Device Evaluation (ODE)