H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM

K043186 · Health & Life Co., Ltd. · DXN · Dec 6, 2004 · Cardiovascular

Device Facts

• Record ID: K043186
• Device Name: H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Manual inflate type blood pressure monitor for measurement of 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 use of this over-the counter device is for adult patients whose arm circumference is between 24-44cm (approx. 9.4" to 17.5").

Device Story

H&L (NIBP) Blood Pressure Monitor (HL888EM) is an over-the-counter, manual-inflation oscillometric device. It measures systolic/diastolic blood pressure and heart rate; displays values on an integrated LCD panel. Designed for adult home use; patient operates device by manually inflating cuff. Oscillometric method detects pressure oscillations in cuff during deflation to calculate blood pressure and pulse rate. Provides objective data for patient self-monitoring of cardiovascular status.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Oscillometric measurement principle; manual inflation mechanism; LCD display; intended for adult arm circumference 24-44cm.

Indications for Use

Indicated for adult patients with arm circumference 24-44cm for non-invasive 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Health & Life Co., Ltd. c/o Mr. Paul Hung Manager 9F. No. 186. Jian Yi Road Chung Ho City, Taipen Hsien TAIWAN R.O.C.

Re: K043186

Trade Name: H&L (NIBP) Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 08, 2004 Received: November 17, 2004

Dear Mr. Hung:

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 for association 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, de necs that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aroney mains 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 rr your device 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.

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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 may be obtained 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,

Blumman for
R. D. Zalesky, M.D.

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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## <043186

## 510(k) Number (if known) :

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

Trade Name : HL888EM

## Indications For Use

Manual inflate type blood pressure monitor for measurement of 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 use of this over-the counter device is for adult patients whose arm circumference is between 24-44cm (approx. 9.4" to 17.5")."

Prescription USE( (Per 21 CFR 801 109)

OR

Over-The-Counter Use( √ ) ( Optional Format 1-2)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumena

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K013/86
Card Devices