MODIFICATION TO: HL168W TOUCH SCREEN

K013033 · Health & Life Co., Ltd. · DXN · Oct 23, 2001 · Cardiovascular

Device Facts

• Record ID: K013033
• Device Name: MODIFICATION TO: HL168W TOUCH SCREEN
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 23, 2001
• 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 read out in one LCD panel. The intended for use of this over-the-counter device is for age 16 and above.

Device Story

HL168W 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 age 16 and older; device displays results on integrated LCD panel; provides automated physiological monitoring for home use; assists users in tracking blood pressure trends.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification and regulatory review.

Technological Characteristics

Non-invasive blood pressure measurement system; oscillometric sensing principle; LCD display; intended for over-the-counter use; Class II device (Product Code: DXN).

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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OCT 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Yang General Manager Health & Life Co., Ltd. 6F, No. 407, Chung Shan Road Sec. 2. Chung Ho City Taipei Hsien TAIWAN R.O.C.

Re: K013033

Trade Name: HL168W Touch Screen Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 24, 2001 Received: October 1, 2001

Dear Mr. Yang:

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 Yang

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 that I DA has made a associations administered by other Federal agencies. You must of any I edelal statutes and regulations and using, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, n.c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFK Fatt 607), labeling (21 CFR Part 820), good if applicable, the electronic forul in the quality systems (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) I ms letter will anow you to ough mains of substantial equivalence of your device to a legally premaired predicated on: "The PDF intellight on 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 and If you desire specific authority of your avitro diagnostic devices), please contact the Office of additionally 21 CT N Fall 607.10 for mirraally, for questions on the promotion and advertising of Compliance at [phone]. The Office of Compliance at [phone]. Also, please note the your device, prease ochiasonding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your respectional 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,

Dale Tell

~ James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known) : K013033

Device Name: Full Automatic (NIBP) Blood Pressure Monitor

Trade Name : HL168W

Indications For Use

Measures automatically 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 for 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 (V) (Optional Format 1-2)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013053

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