MODIFICATION TO HL168

K033043 · Health & Life Co., Ltd. · DXN · Oct 10, 2003 · Cardiovascular

Device Facts

• Record ID: K033043
• Device Name: MODIFICATION TO HL168
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 10, 2003
• 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 uping the oscillometric method. All values can be read out in one LCD Panel. The intended use of this over-the counter device is for age 16 and above,

Device Story

HL168N is an automatic non-invasive blood pressure (NIBP) monitor; utilizes oscillometric method to measure systolic/diastolic blood pressure and heart rate; intended for over-the-counter use by individuals aged 16 and above; device features LCD panel for display of measured values; operates as a standalone unit; provides automated physiological data to user for health monitoring.

Clinical Evidence

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

Technological Characteristics

Non-invasive blood pressure measurement system; oscillometric sensing principle; automatic inflation/deflation; LCD display; standalone device; Class II; Product Code DXN.

Indications for Use

Indicated for individuals aged 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

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

Re: K033043 Trade Name: HL168N Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 25, 2003 Received: September 29, 2003

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.

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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 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,

CRogers Meyer

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) : K033043

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

Trade Name : HL168N

## Indications For Use

Measures automatically human's Systolic, Diastolic blood pressure and heart rate uping the oscillometric method. All values can be read out in one LCD Panel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription USE ( (Per 21 CFR 801.109) OR

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

Mersmyer for BRT
(Division Sig)

Division of Cardiovascular Devices

510(k) Number_K033043

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