H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF

K050491 · Health & Life Co., Ltd. · DXN · Mar 31, 2005 · Cardiovascular

Device Facts

• Record ID: K050491
• Device Name: H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF
• Applicant: Health & Life Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measures automatically human beings 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 adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").

Device Story

H & L Full Automatic (NIBP) Blood Pressure Monitor (models HL888KA, HL888LF, HL888IF) is an over-the-counter device for adult use. It utilizes the oscillometric method to measure systolic and diastolic blood pressure and heart rate. The device features an inflatable cuff and an LCD panel for displaying results. It is intended for home use by patients to monitor their own blood pressure. The device provides automated readings, allowing users to track cardiovascular metrics without professional assistance. The output assists users in monitoring their health status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oscillometric measurement principle; LCD display; arm cuff for circumferences 24cm-44cm; electronic device; standalone operation.

Indications for Use

Indicated for adult patients with arm circumference 24cm-44cm for automatic measurement of systolic/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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050491

: K050491
Trade Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL888KA, HL888LF and HL888IF Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 22, 2005 Received: March 28, 2005

Dear Mr. Hung:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainted is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and nave determined the actress aredicate devices marketed in interstate for use stated in the encrosule) to tegally manatise perios Americal Device Ameralments, or to commerce prior to May 28, 1970, the charge with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the A and Cosmetic Act (Act) that do not require approval or a provisions provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, merelore, market the device, sucject to the gently for annual registration, listing of general controls provisions of the free merals of the more of the mastern 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 (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may be subject to such additional controller Entroling and on 898. In addition, FDA may be found in the Code of Peachartogeming 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 Please be advised that FDA's issualice of a substantial with other requirements of the Act
that FDA has made a determination that your device addes areas. You must that FDA has made a determination inal your areas of other Federal agencies. You must in the or any Federal statutes and regilations and united or registration and listing (21)
comply with all the Act's requirements, including, but not associae requirements as set comply with all the Act s requirements, moradias variasturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electron CFR Part 807); labeling (2) CFR Parl on ); good manata and (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Patt 820); and 1f ap forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (Scetions 911 device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your avvoe on your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of you premarket notification. The FDA initing of substantial equive 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
rs of the many of the many of 10, 276, 0100 - Algeraliation entitled If you desire specific advice for your ac not on on on on on on one mote the regulation entitled, would of the regulation contact the Office of Complaned at (216) 215 or and 807.97). You may obtain "Misbranding by relerence to premance notified.com (the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638other general information on your responsionnes and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-ifrememain html Manufacturers, International and Consumer Piess over drh/dsma/dsmamain.html

Sincerely yours,

U. Mefayxop

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

510(k) Number (if known): _K050491

## Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor,___ HL888KA, HL888LF, HL888IF

Indications for Use:

Measures automatically human beings 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 adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Ose _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Melendez-Negron

(Division Sign-Of) /
Division of Cardiovascular Devices
510(k) Number K050991