Arm Blood Pressure Monitor

• K Number: K192023
• Device Name: Arm Blood Pressure Monitor
• Manufacturer: Truly Instrument Limited
• Date Cleared: 2019-12-23 ( 147 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Device Description

Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%. The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

Predicate Devices

K161846

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard oscillometric blood pressure measurement and basic irregular pulse detection based on time interval analysis, without mentioning AI or ML algorithms.

Therapeutic

No.
The device is intended to measure and monitor blood pressure and pulse rate, not to treat a condition.

Diagnostic

Yes
The device measures systolic and diastolic blood pressure and pulse rate, and also detects irregular pulse rhythms, which are all parameters used to diagnose or monitor medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, operation keys, pump, electromagnetic deflation control valve, and LCD. While it includes software functionality (Bluetooth data transmission, irregular pulse detection), it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this device measures blood pressure and pulse rate using a non-invasive technique involving an inflatable cuff wrapped around the upper arm. It analyzes pressure changes and electrical signals from a sensor.
• No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The measurement is performed externally on the body.

Therefore, the device described is a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .

Product codes

DXN

Device Description

Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.

The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.

The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm

Indicated Patient Age Range

Adult

Intended User / Care Setting

Home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device.

Key Metrics

Accuracy Pressure: +/- 3mmHg
Accuracy Pulse: +/- 5%

Predicate Device(s)

K161846

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 23, 2019

Truly Instrument Limited % Max Wong Official Correspondent Truly (U.S.A) Inc 2620 Concord Avenue, Suite 106 Alhambra, California 91803

Re: K192023

Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 29, 2019 Received: November 29, 2019

Dear Max Wong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

1

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192023

Device Name

Arm Blood Pressure Monitor

Indications for Use (Describe)

Truly Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone]

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Image /page/3/Picture/0 description: The image shows the text 'K192023' in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, making the text easily readable.

Image /page/3/Picture/1 description: The image shows the word "TRULY" in red, bold letters. To the right of the word is a circled R, indicating that the word is a registered trademark. A black line is located underneath the word.

510(k) Summary

V1.0

Date of Summary Preparation: May 21.2019

1. Submitter's Identifications

Submitter's Name:	Truly Instrument Limited
Address:	Site 2, Truly Industrial Area, Shanwei City,
Guangdong Province, China
Contact Person:	Manager Su-HaiSen
Telephone:	86-0660-3363561
Fax:	86-0660-3380377

2. Name of the Device

Device Classification Name:	System, Measurement, Blood-Pressure, Non-invasive
Trade Name:	Arm Blood Pressure Monitor
Models:	DB66-1, DB68
Classification Panel:	cardio-vascular
Common/Usual Name:	Automatic Arm Blood Pressure Monitor
Product Code:	DXN
Device Classification:	Class II
Contraindications :	N/A

3. The Predicate Devices

TRULY Instrument Limited.

Truly Automatic Arm Bluetooth Blood Pressure Monitor DB Series, Model DB62 510 K Number : K161846

4. Device Description

Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".

The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD.

The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of

4

Image /page/4/Picture/1 description: The image contains the word "TRULY" in large, bold, red letters. To the right of the word, there is a circled "R" symbol, indicating that the word is a registered trademark. The word is slightly slanted to the right, giving it a dynamic appearance. The background is plain white.

irregular pulse rhythm when the difference of the time intervals is over 25%.

The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.

5. Intended use of device

Automatic Arm Blood Pressure Monitor DB series, Models DB66-1, DB68 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .

6. Technological Characteristics of our new DEVICE COMPARED TO THE

PREDICATE DEVICE:

The technological characteristics of Automatic Arm Blood Pressure Monitor, models DB66-1, DB68 are substantially equivalent to Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62.( K161846). There is the same Owner, TRULY instrument Limited. Which FDA owner number is 9054344. In addition, there are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.

| Parameter | Predicate Devices DB62 | DB66-1 | DB68 | Explanation of the
differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------|
| Intended use | Measuring systolic and diastolic blood
pressure and pulse rate of adult individual | Measuring systolic and diastolic blood
pressure and pulse rate of adult individual | Measuring systolic and diastolic blood
pressure and pulse rate of adult individual | Identical |
| The trade name | Automatic Arm Bluetooth Blood Pressure
Monitor | Arm Blood Pressure Monitor | | Identical |
| 510(K) Number | K161846 | | | |
| Applicant | Truly Instrument Limited. | Truly Instrument Limited. | | Identical |
| Regulatory Class | Class II | Class II | | Identical |
| Panel | Cardiovascular | Cardiovascular | | Identical |
| Product Code | DXN | DXN | | Identical |
| Indications for
use | Truly Automatic Arm Bluetooth Blood
Pressure Monitor DB62 is intended to
measure the systolic and diastolic blood | Truly Automatic Arm Bluetooth Blood
Pressure Monitor DB62 is intended to
measure the systolic and diastolic blood | | Identical |

Table-1: The comparison table

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| TRULY®

r
-------------	--

Parameter	Predicate Devices DB62	DB66-1	DB68	Explanation of the differences
	pressure and pulse rate of an adult
individual by using a non-invasive
technique in which an inflatable cuff is
wrapped around the upper arm.
The devices' features include irregular
pulse rhythm detection during
measurement, and will display a alert
signal with the reading when irregular
heartbeat is detected.
The devices' feature include Bluetooth
function to transmit data to an external
Bluetooth device with wireless
communication .. Over-The-Counter Use	pressure and pulse rate of an adult
individual by using a non-invasive
technique in which an inflatable cuff is
wrapped around the upper arm.
The devices' features include irregular
pulse rhythm detection during
measurement, and will display a alert
signal with the reading when irregular
heartbeat is detected.
The devices' feature include Bluetooth
function to transmit data to an external
Bluetooth device with wireless
communication .. Over-The-Counter Use
Target
Population	Adult	Adult		Identical
Anatomical sites	Upper Arm	Upper Arm		Identical
Where used
(hospital, home,
ambulance. etc)	Home	Home		Identical
Energy used and
/ or delivered	4x 1.5V AA Battery	Polymer battery
DC3.7V,
500mAh	4x 1.5V AA
Battery	Equivalent
The change in the
specification is
documented and
tested,does not
affect the intended
use or the
fundamental
scientific
technology.
Human factors	Blood pressure	Blood pressure		Identical
performance	Measuring systolic and diastolic blood
pressure and pulse rate of adult individual,
Including irregular pulse rhythm detection	Measuring systolic and diastolic blood
pressure and pulse rate of adult
individual, Including irregular pulse
rhythm detection		Identical
biocompatibility	Cuff
According to ISO-10993	Cuff
According to ISO-10993		Identical
Compatibility with
the environment
and other devices	Operation Environment:
10°C~40°C,15%~90%RH
Storage Environment:
-20°C~60°C,10%~95%RH
Atmospheric:70KPa~106KPa	Operation Environment:
10°C~40°C,15%~90%RH
Storage Environment:
-20°C~60°C, 10%~95%RH
Atmospheric 70KPa~106KPa		Identical

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| Parameter | Predicate Devices DB62 | DB66-1 | DB68 | Explanation of the
differences |
|-------------------|------------------------------------------------------|------------------------------------------------------|------|-----------------------------------|
| Electrical safety | According to IEC60601-1-2
According to IEC60601-1 | According to IEC60601-1-2
According to IEC60601-1 | | Identical |
| Sterilization | N/A | N/A | | Identical |
| Chemical safety | N/A | N/A | | Identical |
| sterility | N/A | N/A | | Identical |
| Thermal safety | N/A | N/A | | Identical |
| design | Refer to Table-2 | | | |
| materials | Refer to Table-2 | | | |

Table-2: The comparison table in Design and Materials

Parameter	Predicate Devices DB62	DB66-1	DB68
Measurement algorithm
Method	Oscillometric method	No change ,all same	No change ,all same
Measurement site of
body	Arm	No change ,all same	No change ,all same
Max Cuff pressure	300mmHg	No change ,all same	No change ,all same
Bluetooth	BG312	H04J08C
Irregular
heartbeat
detection	More than $\pm$ 25% to the
mean interval of pulse
intervals.
About the more detailed
description of the IH detection
algorithm, please refer to
"Software validation report
I-5. Algorithm description 4.
Determination method of
irregular heartbeat".	No change ,all same	No change ,all same
Measurement Pressure
Range	20 ~ 280 mmHg	No change ,all same	No change ,all same
Measurement Pulse
Range	40 ~ 195 beats/min	No change ,all same	No change ,all same
Mesauring resolution	1 mmHg	No change ,all same	No change ,all same
Accuracy Pressure	$\pm$ 3mmHg	No change ,all same	No change ,all same
Accuracy Pulse	$\pm$ 5%	No change ,all same	No change ,all same
Cuff Deflation	Automatic deflation	No change ,all same	No change ,all same
Pressurization Source	Automatic internal pump
DC6V	Automatic internal pump
DC3V	Automatic internal pump
DC6V
Power Voltage	4X 1.5V	Polymer battery
DC3.7V,500mAh	4x 1.5V AA Battery
Operating Environment	1040℃, 1590%RH	No change ,all same	No change ,all same
Storage Environment	-20°C~60°C,10%~95%RH	No change ,all same	No change ,all same

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Truly Instrument Limited
Parameter	Predicate Devices DB62	DB66-1	DB68
Memory Size	4 x 99	99	99
Display Type	Liquid crystal display	Liquid crystal display ,Only difference size
Cover		Difference

7. Summary of Clinical study

Testing Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device. Compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device.

8. Non-Clinical Tests Performed:

• 8. Test Summary:
     8-1. Electric Safety , EMC and FCC test reports.

| General safety | IEC 60601-1:2005+A1:2012
Medical electrical equipment-
Part1: General requirements for safety and essential performance
IEC60601-1-11:2015
Medical electrical equipment-Part 1-11: General Requirement for
basic safety and essential performance- Collateral Standard:
Requirements for medical electrical systems used in the home
healthcare environment
EN60950-1:2013
Information technology equipment-Safety- Part1:General
requirements |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EMC conformity | IEC 60601-1-2:2014
Medical Electrical Equipment - Part 1-2: General requirements for
safety - collateral standard: Electromagnetic compatibility -
Requirements and Tests |
| FCC conformity | FCC 47 part 15 subject B class B |
| ERM conformity | EN301489-1:2017;EN301489-17:2017 |
| RF conformity | EN300328:2016 |
| Health | EN62479:2010 |

8-2. Reliability & Clinical Test

| IEC80601-2-30:20019
+A1:2013 | Medical electrical equipment -
Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometer |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 81060-2:2013 | Non-invasive sphygmomanometers – Part 2: Clinical validation |

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Image /page/8/Picture/1 description: The image contains the word "TRULY" in large, red, bold letters. To the right of the word is a small, red circle with the letter R inside, indicating a registered trademark. There is a black line underneath the word "TRULY".

of automated measurement type

8.3 Biocompatibility Test

| ISO10993-1:2009 | Biological evaluation of medical devices-Part 1: evaluation and
testing |
|------------------|--------------------------------------------------------------------------------------------|
| ISO10993-5:2009 | Biological evaluation of medical devices-Part 5: Test for
cytotoxicity in vitro methods |
| ISO10993-10:2010 | Biological evaluation of medical devices-Part 10: Tests for irriation
and sensitization |

9. Conclusions

The new subject devices of Arm Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DB62(K161846), and the feature, safety, effectiveness are also as same as DB62., Thus, the subject devices are substantially equivalent to the predicate devices.