HL168JP

K050249 · Health & Life Co., Ltd. · DXN · Mar 30, 2005 · Cardiovascular

Device Facts

• Record ID: K050249
• Device Name: HL168JP
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 30, 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. One or two readings will not provide a true indication of your normal blood pressure. It is very important to take regular, daily measurements and to keep a record. I would be and home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.

Device Story

H&L Full Automatic (NIBP) Blood Pressure Monitor (HL168JP) is an oscillometric device for home use. It measures systolic/diastolic blood pressure and heart rate; displays results on an integrated LCD panel. Device intended for regular, daily self-measurement to track blood pressure trends over time. Data assists patients and physicians in diagnosing and managing health conditions. Operation involves cuff inflation/deflation and automated signal processing to determine pressure values.

Technological Characteristics

Oscillometric blood pressure measurement system; integrated LCD display; automated cuff inflation/deflation mechanism.

Indications for Use

Indicated for human beings to measure systolic/diastolic blood pressure and heart rate via oscillometric method. Intended for regular, daily home monitoring to assist in diagnosing and preventing health problems in partnership with a physician.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

MAR 3 0 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: K050249

K 050249
Trade Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (HL168JP) Regulation Number: 21 CFR 870.1130 Regulation Name: 21 OF R 07071159
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 21, 2005 Reccived: March 23, 2005

Dear Mr. Hung:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and have determined the assessed predicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 28, 1970, the chaemient auto shown of the Federal Food, Drug, devices that have been reclassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, lighten, diginal You may, merelore, market the devree, salges to the general registration, listing of
general controls provisions of the Act include requirements for annual registration, list general controls provisions of the necesses of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (see above) nito entist sure regulations affecting your device can
may be subject to such additional controls. Existing major regulations diDame may be subject to such additional controller Existing may one of the 21, In addition, I'DA may be found in the Code of Peachartergerning 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 Please be advised that FDA s issuance of a subscunter oquirements of the Act
that FDA has made a determination that your device Forexal agencies. You must that FDA has made a determination that your develop of er Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listing or any Federal statutes and regulations administed or registration and listing (2)
comply with all the Act's requirements, including, but not treation requirements as set comply with all the Act s requirences, menames our open ice requirements as set
CFR Part 807); labeling (21 CFR Part 801); groom at 200); explicable, the electronic CFR Part 807); labeling (21 CFR Part on ); good manananing manufacelle, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scetions 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active ap walence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your d premarket notification. The FDA inding of substantial equivation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs of the may be and and 100 and been the regulation entitled If you desire specific advice for your de need on our of not a Also, please note the regulation entitled, white contact the Office of Complance at (246) 276 of (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket noutheausneder the Act from the Division of Small
other general information on your responsibilities under the Act from www.org.000 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-demanain html Manufacturers, International and Combanier 14-15-1
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Brimmer for

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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## Indications for Use

510(k) Number (if known): _K050249_

Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL168 JP

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.

One or two readings will not provide a true indication of your normal blood Ghe of the is very important to take regular, daily measurements and to keep prood. I would be and home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Blummo