HL888SF

K060835 · Health & Life Co., Ltd. · DXN · Apr 21, 2006 · Cardiovascular

Device Facts

• Record ID: K060835
• Device Name: HL888SF
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 21, 2006
• 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 by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.

Device Story

Device is an automatic non-invasive blood pressure (NIBP) monitor; model H1.888SF. Uses oscillometric method to measure systolic/diastolic blood pressure and heart rate. Input is pressure oscillation data from an inflatable cuff; output is numerical values displayed on an integrated LCD panel. Designed for over-the-counter (OTC) use by adults over 18. Provides patients with a convenient method for monitoring blood pressure and heart rate at home, facilitating self-management of cardiovascular health.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

Oscillometric measurement principle; automatic inflation/deflation system; integrated LCD display; standalone device; intended for OTC use.

Indications for Use

Indicated for adults over 18 years of age for the automatic measurement of systolic and diastolic blood pressure and heart rate.

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 2 1 2006

I Icalth & Life Co., Ltd. Regulation Department c/o Alex Kou Quality Representative 9F., NO. 186. Jian Yi Road Chung Ho City, Taipei County TAIWAN 23553

Re: K060835

Trade Name: Full Automatic (NIBP) Blood Pressure Monitor. Model H1.888SF Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 17. 2006 Received: March 27, 2006

Dear Mr. Kou:

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. Alex Kou

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 (OS) 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.lda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimman 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

5 10(k) Number (if known): K060835

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

Indications for Use:

Measures automatically human's Systolic, Diastolic blood pressure and heart rate by using the oscillornetric method. All values can be read out in one LCD panel. The intended use of this over-the-counter-device is for over the age of 18.

Prescription List ____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use ... } AND/OR (Part 21 CFR 801 Subpart D) (2) CFR SD, Subpartu i

(PLÈASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE OF NEEDEDI

Companya. 1 CDRH. Offic, of Deace Budustion (1) 08

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Bhemmma
(Division Sign-Off)
Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K060835