[Company Information]

□ Name : BISTOS Co., Ltd.

□ Website Address : www.bistos.co.kr

□ Location

○ Headquarters : 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

○ Research Center : Same as above

○ Manufacturing Plants 1 : Same as above

○ Manufacturing Plants 2 :

□ Contacts Department

○ Contacts : sales@bistos.co.kr

Address: Same as above

Tel.: +82-31-750-0340

Fax: +82-31-750-0344

□ Manufacturer Information : See attached company profile.

[Medical device Information]

□ Product 1

○ Name : BT-300 Fetal Monitor

○ Intended use : The BT-300 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices and in the patient’s home.

□ Product 2

○ Name : BT-350 LED Display Fetal Monitor

○ Intended use : The BT-350E is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices and in the patient’s home.

□ Product 3

○ Name : BT-350 LCD Display Fetal Monitor

○ Intended use : The BT-350L is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices and in the patient’s home.

□ Product 4

○ Name : BT-200 Fetal Doppler

○ Intended use : BT-200 Fetal Doppler is a pocket-size fetal Doppler that measures the fetal heart rate (FHR) and output the fetal heart sound through built-in speaker.

Measuring the FHR gives an indication of fetal well-being.

□ Product 5

○ Name : BT-220 Fetal Doppler

○ Intended use : The BT-220 is a potable fetal Doppler that measures the fetal heart rate and outputs the fetal heart sound through a built-in speaker. Measuring the fetal heart rate(FHR) gives an indication of fetal well-being.

□ Product 6

○ Name : BT-250 Tabletop Fetal Doppler

○ Intended use : The BT-250 is a desktop fetal doppler that measures the fetal heart rate and outputs the fetal heart sound through a built-in speaker. Measuring the fetal heart rate(FHR) gives an indication of fetal well-being. This data is intended to aid in assessing the well being of the fetus (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices and in the patient’s home.

□ Product 7

○ Name : BT-200 Vascular Doppler

○ Intended use : BT-200 Vascular Doppler HI • dop is a pocket-sized vascular Doppler that measures the blood flow and outputs the heart or blood sound through a built-in speaker.

□ Product 8

○ Name : BT-700 Tabletop Pulse Oximeter

○ Intended use : The BT-700 is a Patient monitor. It measures the SpO2, pulse rate. It provides continuous and noninvasive information on two important physiological parameters: arterial blood oxygen saturation and pulse rate. This information is obtained through measurement of light intensity transmitted across the finger at two distinct wavelengths, in the red and near-infrared regions of spectrum. This monitor measures functional saturation – oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation – oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins.

BT-700 has the Auto-calibration functions for each other patient. Internal calibration function starts calibrating when the patient is monitored.

This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices.

□ Product 9

○ Name : BT-750 Multi Parameter Patient Monitor

○ Intended use : BT-750 is a patient monitor which displays state of patient’s data with wave form. Basic functions are measuring ECG 3lead select and respiration. Also it is possible to measuring arrhythmia, analysis ST level and detects pacemaker function. Other basic functions are measuring SpO2, pulse rate, NIBP, 2 IBP and 2 body temperatures. Optional functions are ECG 5 lead select and EtCO2 measurement.

□ Product 10

○ Name : BT-410 Medical Headlamp

○ Intended use : The BT- 410 Head-worn light allows doctors to examine with a clear eye onto the affected part by wearing it onto the head.

□ Product 11

○ Name : BT-400 Phototherapy

○ Intended use : BT-400 Phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

□ Product 12

○ Name : BT-500 Infant Incubator

○ Intended use : BT-500 is an infant incubator for non-invasively measuring and showing graphically humidity, air temperature, skin temperature, weight and SpO2. This data is intended to aid the maintaining life of a premature baby or a precocious baby under 2kgs. This device is for use only by trained medical personnel located in hospital. Also this device can be used in the all departments of the hospital which offers a neonatal care service such as NICU(Neonatal Intensive Care Unit), special nursery unit and pediatrics.

□ Product 13

○ Name : BT-550 Infant Warmer

○ Intended use : The BT-550 is intended to emit controlled, evenly distributed overhead heat to the body of premature infant and other newborns who cannot effectively regulate their body temperature. This device can be used before any treatment or operation of infant.

□ Product 14

○ Name : BT-100 Breast Pump

○ Intended use : Breast pumps are intended to be used by lactating women for expressing breast milk in home environments. Expressing milk by breast pump is indicated to alleviate the symptoms of engorgement. In case of symptoms of mastitis, breast pumps may support the healing process by removing breastmilk from the affected breast.