FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS

K050714 · Health & Life Co., Ltd. · DXN · Apr 7, 2005 · Cardiovascular

Device Facts

• Record ID: K050714
• Device Name: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
• 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 read out in one LCD panel. The intended use of this over-the-counter-device is for age 16 and above.

Device Story

The HL168GA and HL168GS are automatic non-invasive blood pressure (NIBP) monitors. The device utilizes the oscillometric method to measure systolic/diastolic blood pressure and heart rate. It is intended for over-the-counter use by individuals aged 16 and older. The device operates by inflating a cuff, sensing pressure oscillations, and processing these signals to calculate blood pressure and heart rate values. Results are displayed on an integrated LCD panel. The device is designed for home use, allowing patients to monitor their own vital signs without physician assistance. The output provides users with objective data to track blood pressure trends, which may assist in the management of cardiovascular health.

Clinical Evidence

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

Technological Characteristics

Non-invasive blood pressure monitor using the oscillometric measurement method. Features an integrated LCD display for output. Operates as a standalone device. No specific materials, energy sources, or software architecture details provided.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 2005

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: K050714

Trade Name: HL168GA and HL168GS 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 wt nave reviewed your becamed 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 conninered provided in accordance with the provisions of the Federal Food, Drug, devices that have boon roomstiled in actre approval of a premarket approval application (PMA). and Costience Act (71ct) that do not require to the general controls provisions of the Act. The r ou may, mercere, manel of the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 classified (boo ace royals. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff Inay be subject to subli additional connections, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Over in concerning your device in the Federal Register. publish lurner announcents vonce of a substantial equivalence determination does not mean Frease of advised that I DA 3 localites of the 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/cdrh/dsma/dsmamain.html

Sincerely yours,

B.B.tmmmoe 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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## 510(k) Number (if known) :

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

Trade Name : HL168GA, HL168GS

## 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 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( √ (Optional Format 1-2)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumman

(Division Sign-C Division of Cardiovascular Deylogs 510(K) N

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