[Company Information]

□ Name : i-SENS, Inc.

□ Website Address : www.i-sens.com

□ Location

○ Headquarters : 43, Banpo-daero 28-gil, Seocho-gu, Seoul, 06646, South Korea

○ Research Center : 43, Banpo-daero 28-gil, Seocho-gu, Seoul, 06646, South Korea

○ Manufacturing Plants 1 : 94-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, 26365 Korea

○ Manufacturing Plants 2 : 12, Harmony-ro 275 beon-gil, Yeonsu-gu, Incheon, 22014 Korea

□ Contacts Department

○ Contacts : 43, Banpo-daero 28-gil, Seocho-gu, Seoul, 06646, South Korea (3F, Sales Department)

□ Manufacturer Information : i-SENS Brochure (Attachment 1)

[Medical device Information]

□ Product 1

○ Name : CareSens N Premier Blood Glucose Monitoring System

○ Intended use : The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions.

The CareSens N Premier Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

The CareSens Control Solutions are for use with the CareSens N Premier Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly

○ Images : Product image (Attachment 2)

○ Attachment : Specifications & Features of a Bluetooth enabled CareSens N Premier Meter (Attachment 3)

□ Product 2

○ Name : A1Care™ Analyzer

○ Intended use : The A1Care™ Analyzer is designed for point-of-care testing to quantitatively measure the glycated hemoglobin (HbA1c) in whole blood and to report the result as a ratio of HbA1c to total hemoglobin.

As accessories for the analyzer, the Barcode Reader is used to scan barcoded patient identification and input scanned information to the analyzer. The Thermal Printer is used to print the test results with patient test.

○ Images : Product image (Attachment 4)

○ Attachment : A1Care™ Leaflet (Attachment 5)

[Attachment 1 - Company and products]

1. Manufacturer Information (1. I20150909_isens brochure_final.pdf)

[Attachment 2, 3 – (BGMS) CareSens N Premier

2. Product Image (2. CS N Premier_FRONT_Backlight.jpg)

3. Specifications and Features of the Bluetooth enabled meter (3. CS N Premier BLE_part of brochure.pdf)

[Attachment 4, 5 – (HbA1c Analyzer) A1Care™ Analyzer

4. Product Image (4. A1Care™_product_image.jpg)

5. Product leaflet (5. D023 REV0 A1Care_leaflet_A4_150925s.pdf)