TEL:886-2-27514486 886-2-27528419 7F-4,NO: 246, SEC,2,CHANG-AN EASTRD.,TAIPEI,TAIWAN.

FAX:886-2-27732381    E-Mail Address: barchen.co@msa.hinet.net

hersmedical@hersmedical.com.tw Frank.hsieh@hersmedical.com.tw

Mobile Phone: 886 0918 730451

http://www.hersmedical.com.tw  http://www.hersmedical.com 

 http://www.barchens.com.tw  

              510(K) SUMMARY

Submitter’s Name:  HERS MEDICAL CO., LTD

                     7F-4 NO : 246 SEC .2 CHANG-AN EAST RD., TAIPEI TAIWAN

Date summary prepared:                                                                  Sept. 10, 2004

Device Name:

        Propietary Name:    HERS  MEDICAL Blood Pressure Monitor, Model No: YS-796, YS-818, YS-793,

                                          YS-794, YS-795, YS-805, YS-807 and same series model number.

        Common or Usual Name: NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

        Classification Name:  Blood Pressure Monitor, Class II,

                              CFR 870.1130

Indications for Use:

          The above mentioned device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18,

          At home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist

          And Arm. The cuff circumference is limited to be 5.25– 7.75.

Description of the device:

                 HERS MEDICAL Blood Pressure Monitor, Model No: YS-796, YS-818, YS-793, YS-794, YS-795,

                 YS-805, YS-807 and same series model number. Uses the Oscillometric method to measure the blood

pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently.

It is not needed to use the stechoscope, as in the traditional measuring method, to monitor the

Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses

the vibrating signal via the closed air pipe system. And utilizes the microcomputer to automatically

sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the

reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the

pressure when the cuff pressure Oscillating amplitude begins to increase and the diastolic pressure as

the pressure when the cuff pressure oscillating amplitude stops decreasing.

Performance Testing:

Electric Safety Requirement Test Report of EN 60601-1:1990 & EN 1060-1/EN1060-3,

And EMC test report of EN 60601-1-2(EN 55011:1991and EN 6100-4-2:1995)

ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers

Legally marketed device for substantial equivalence comparison:

EikonAutomatic Digital Blood Pressure Monitor, HD-400M(K021239)

Summary for substantial equivalence comparison:

Same characteristics: intended use, technological characteristics, power supply, display, measuring

Range, accuracy, operating and storage environments.

Different characteristics: memory, dimensions, weight, and storage environments

1.              As we can understand, the memory feature is to memorize the measurement data taken

Previously and is related to the usage convenience, not to raise any safety or effectiveness hazard.

2.              The differences between dimensions and weight are related to the designing aspects.

These differences are not to raise any safety or effectiveness aspect.

They are decided to be substantially equivalent.  of Pen Shape