FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM

K050587 · Health & Life Co., Ltd. · DXN · Apr 5, 2005 · Cardiovascular

Device Facts

• Record ID: K050587
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measures automatically human beings 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

Device is an automatic non-invasive blood pressure (NIBP) monitor (models HL888KM, HL888DM) for over-the-counter use. It utilizes the oscillometric method to measure systolic/diastolic blood pressure and heart rate. Input is obtained via an arm cuff; device processes pressure oscillations to calculate hemodynamic parameters. Output is displayed on an integrated LCD panel. Intended for adult patients in home or clinical settings. Provides automated readings to assist users in monitoring blood pressure trends.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; automatic inflation/deflation; LCD display; arm cuff for 24-44cm circumference; standalone battery-operated 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

APR - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Health and Life Co, Ltd. c/o Mr. Paul Hung Manager, Regulation Department 9F, NO. 186, Jian Yi Road Chung Ho City, Taipei Hsien (235) Taiwan R.O.C.

## Re: K050587

R020507
Trade Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (HL888KM, HL888DM) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 29, 2005 Received: March 31, 2005

Dear Mr. Hung:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected by ready for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to trg.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been receive approval of a premarket approval application (PMA). and Costicule recry recry that as novice, subject to the general controls provisions of the Act. The I ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 elassified (600 a0070). Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements 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 r lease oe actived that I Dr over device complies with other requirements of the Act that I Dr Has Intact a avoid regulations administered by other Federal agencies. You must or any I catal the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Not 310 cart 801); good manufacturing practice requirements as set CI It Far 6077; adomig (Dr CFR egulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) rms letter will and my your e FDA finding of substantial equivalence of your device to a legally premainst notification - 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 11 you desire specific administrat [phone]. Also, please note the regulation entitled, Connect the Office of Court County of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on your response 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. Zimmerman for

Bram D. Zuckerman, M.I Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): _______________________

Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL888KM, HL888DM

Indications for Use:

Measures automatically human beings 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").

Blumuma

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K0505

Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use V (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)