FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT

K050711 · Health & Life Co., Ltd. · DXN · Apr 7, 2005 · Cardiovascular

Device Facts

• Record ID: K050711
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 7, 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 ressure and heart rate measurements will be announced in English (suit measurements will be announced in English (optional). The intended use of this over-the counter device is for age 16 and above.

Device Story

HL168JT is an automatic, over-the-counter, non-invasive blood pressure monitor. Device uses oscillometric method to measure systolic/diastolic blood pressure and heart rate. Intended for patient self-use at home for individuals aged 16 and older. Device features optional English voice announcement of measurement results. Provides digital display of vital signs to assist users in monitoring cardiovascular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; automatic inflation/deflation; digital display; optional voice output; intended for over-the-counter use.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting unity and cooperation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 APR 7

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

Re: K050711

Trade Name: HL168JT Full Automatic Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 17, 2005 Received: March 18, 2005

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 commerce prior 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, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject 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. 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

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## Page 2 - Mr. Paul Hung

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/cdrl/dsma/dsmamain.html

Sincerely yours,

Blummanfor

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) :

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

Trade Name : HL168JT

## Indications For Use

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

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

Prescription USE ( ) (Per 21 CFR 801.109)

OR

Over-The-Counter Use( √ ) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Brammer

Ulvision Sign-Off sivision of Cardlovascular Devices 310(k) Number

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