K Number
K200437
Device Name
Blood Pressure Monitor
Date Cleared
2020-06-25

(122 days)

Product Code
Regulation Number
870.1130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.
Device Description
The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel. The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.
More Information

Not Found

No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components in its description, intended use, or testing.

No
The device is a blood pressure monitor intended for measurement, not for treatment.

Yes

Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess a person's health status and can indicate the presence of certain medical conditions.

No

The device description explicitly states it is a sphygmomanometer with an electronic manometer, inflatable cuff, transducer, and LED panel, indicating it is a hardware device with integrated software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
  • Device Function: The Blood Pressure Monitor described measures blood pressure and pulse rate by applying a cuff to the upper arm and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a specimen.
  • Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters measured directly from the patient.
  • Device Description: The description confirms it's a sphygmomanometer for indirect measurement using an inflatable cuff.

Therefore, since the device does not analyze specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel.

The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human being's upper arm

Indicated Patient Age Range

adults, Not suitable for neonatal and infants.

Intended User / Care Setting

medical facilities or at 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

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. 90 patients (42 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Test Summary: Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report. 90 patients (42 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

Non-Clinical Test Summary: The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows: IEC 60601-1:2005+Am1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 80601-2-30:2018, IEC 81060-1:2007.

The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device C02 in the group of 90 subjects (42 male and 48 female, patient age between 17 to 74) with qualified distribution. There was not adverse effects ad complication during clinical testing. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190507

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 25, 2020

Shenzhen Jamr Technology Co., Ltd. Luo Fusheng Management Representative 2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, Guanlan town. Shenzhen, 518110 CHINA

Re: K200437

Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 12, 2020 Received: May 29, 2020

Dear Luo Fusheng:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

510(k) Number (if known)

K200437

Device Name Blood Pressure Monitor

Indications for Use (Describe)

The Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

001 510(k) Summary Version: 1.1

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.

The assigned 510(k) number is:____K200437

1.0 Information of Submitter and Correspondent

Submitter's information:

Shenzhen Jamr Technology Co., Ltd. Address: 2nd Floor, A-building, No.2 Guiyuan Road, Guihua community, Guanlan town, Longhua new district, Shenzhen, P.R.China Phone:+86-755-85292057 Fax: +86-755-61673107 Contact Person: Luo Fusheng E-mail: eng201@cigii.net, reanny@reanny.com

2.0 Device Information

Type of 510(k) submission:Traditional
Trade Name:Blood pressure monitor
Model:C02 and F01
Classification name:System, Measurement, Blood-Pressure, Non-Invasive
Review Panel:Cardiovascular
Product Code:DXN
Device Class:II
Regulation Number:21 CFR 870.1130

3.0 Predicate Device Information

Sponsor:Health & Life Co., Ltd.
Device:Full Automatic (NIBP) Blood Pressure Monitor HL858CL
510(K) Number:K190507

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001 510(k) Summary Version: 1.1

4.0 Device Description

The blood pressure monitor model C02 and F01 are sphygmomanometers with electronic manometer intended to be used for the indirect (non-invasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults during inflation. The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LED panel.

The monitors C02 and F01 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance.

5.0 Intended Use

The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the oscillometric method during inflation. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is 22-40cm (8.7" - 15.7"). Not suitable for neonatal and infants.

6.0 Performance Summary

Clinical Test Summary

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Test report.90 patients (42 males and 48 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2.

Non-Clinical Test Summary

The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:

IEC 60601-1:2005+Am1:2012 IEC 60601-1-2:2014 IEC 60601-1-11:2015 IEC 80601-2-30:2018 IEC 81060-1:2007

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7.0 Comparison to predicate device and conclusion

The subject device is substantially equivalent to predicate devices, K190507, HL858CL. The substantial equivalence chart is provided as follows:

| Elements of
Comparison | Predicate Device
(K190507) | Subject Device | Judgment |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Models | HL858CL | C02 and F01 | -- |
| Company | Health & Life Co., Ltd. | Shenzhen Jamr Technology
Co., Ltd. | -- |
| Device Name | Full Automatic (NIBP) Blood
Pressure Monitor | Blood Pressure Monitor | -- |
| Product code | DXN | DXN | Same |
| Regulation # | 21CFR870.1130 | 21CFR870.1130 | Same |
| Intended use | HL858CL automatically
measures human's Systolic,
Diastolic blood pressure and heart
rate by using the oscillometric
method during inflation. All
values can be read out in one
LCD panel. Measurement
position is at human being's
upper arm. The intended use of
this over-the-counter device is for
adults aged 18 years and older
with arm circumference ranging
from 9 inches to 22 inches
(approx.23 cm to 56 cm) and for
home use.
HL858CL detects the appearance
of irregular heartbeats during
measurement; an indicated
symbol will appear with
measuring reading. And the Risk
Category Indicator will show the
information with the readings on
the screen for the user tracking
their blood pressure level.
Besides, the device features a
built-in "Bluetooth Data
Transmission" function, which | The Blood Pressure
Monitor is intended to
measure the systolic and
diastolic blood pressure as
well as the pulse rate by
using the oscillometric
method during inflation.
Measurement position is at
human being's upper arm.
The intended use of this
over-the-counter device is
for adults at medical
facilities or at home. The
intended upper arm
circumference is 22-40cm
(8.7" – 15.7"). | SE, refer
to Remark
1 |
| Elements of
Comparison | Predicate Device
(K190507) | Subject Device | Judgment |
| Models | HL858CL | C02 and F01 | -- |
| | enables the device automatically
transmit measuring results to
paired Bluetooth-enabled device.
Also, users could simply
synchronize the current date and
time, and check the battery status
of blood pressure monitor by
means of DailyChek® application
software with the paired
Bluetooth-enabled device. | | |
| Measurement
type | Upper arm | Upper arm | Same |
| Patient
population | Adults person over 18 | Adults person | Same |
| Measurement
Item | SYS, DYS, Pulse rate | SYS, DYS, Pulse rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| Measurement
type | During inflation | During inflation | Same |
| BP
measurement
range | 0-300mmHg
Rated Range of Determination:
40280mmHg | 0-295mmHg
Rated Range of
Determination:
SYS:60
255mmHg; DIA:
40200mmHg | SE, refer to
Remark 2 |
| BP accuracy | ±3mmHg (±0.4kPa) | ±3mmHg (±0.4kPa) | Same |
| PR
measurement
range | 40-199 bpm | 40-170 pulses/min | SE, refer to
Remark 3 |
| PR
measurement
accuracy | ±5% of reading | ±5% of reading | Same |
| Power supply | 6V 1A, 4 × AA/1.5V (LR6) Alkaline
batteries, or
AC Adapter (Model: SINPRO,
HPU15-102 Input: 100-240V AC
47-63Hz / Output: 5.99V DC 2A) | d.c. 4.5V, 3*AA batteries; or
AC adapter INPUT: 100-
240VAC 50/60HZ OUTPUT:
5V DC 1A | SE, refer to
remark 4 |
| Elements of
Comparison | Predicate Device
(K190507) | Subject Device | Judgment |
| Models | HL858CL | C02 and F01 | -- |
| Degree of
protection against
electric shock | Type BF applied part | Type BF applied part | Same |
| Type of protection
against electric
shock | Internally power
equipment or class II | Internally power equipment
or class II | Same |
| Model of operation | Continuous operation | Continuous operation | Same |
| Cuff size suitable
for arm size | Arm circumference
approx.
23
43cm / 917 inch
(Universal cuff) | cuff: 8.7" – 15.7" (22 - 40 cm) | SE, refer to
Remark 5 |
| Sets of memory | 2120, total 240 | 2120, total 240 | Same |
| Automatic power off | unknown | Automatically turn off
after 60 seconds | Difference,
Refer to
Remark 6 |
| Operation
environment | 5℃40℃(41°F104°F),
15% ~ 93% R.H.
700
1060hPa | 5°C-40°C, 15%-93%RH,
70-106kPa | Same |
| Storage
environment | -25℃-70℃, ≤ 93% R.H. | -25°C-70°C, ≤ 93% R.H. | Same |
| Performance | Compliance with
Compliance with
ANSI/AAMI/IEC 80601-2-
30 | Compliance with
Compliance with IEC
80601-2-30 | Same |
| Clinical | Compliance with
Compliance with ISO
81060-2 | Compliance with
Compliance with ISO
81060-2 | Same |
| Material | ABS housing and
ABS keys | ABS housing and
ABS keys | Same |
| Biocompatibility | All the patient contacting
materials are compliance
with ISO 10993 | All the patient contacting
materials are compliance
with ISO 10993 | Same |
| Electrical Safety | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Same |
| EMC | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Same |

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001_510(k) Summary
Version: 1.1

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001_510(k) Summary
Version: 1.1

8

001 510(k) Summary Version: 1.1

Remark 1 :

The indication for use of subject device is same as predicate device, only the description is different. The predicate device has irreqular heartbeats, risk category indicator function, and Bluetooth data transmission function. The subject device also has irregular heartbeats function, but not shown in this section. It has been shown in section 6 and section 8.3 of user manual. In additional, this indicator is only a caution, not a diagnostic basis. There is not risk category indicator function and Bluetooth data transmission for our subject device, therefore, this description is not shown. So the difference will not raise any safety or effectiveness issue.

Remark 2:

The blood pressure measurement range and rated range of determination is different between two devices, but they are within the range of predicate device. In additional, the subject device has been passed the testing according to IEC 80601-2-30, ISO 81060-1 and ISO 81060-2 standards. So the difference will not raise any safety or effectiveness issue.

Remark 3:

The PR measurement range of subject device and predicate device is difference, but the range of subject device is within the range of predicate device. In additional, the subject device has been evaluated according to ISO 81060-2 standard. The PR measurement range and accuracy are met the clinical requirements. So the difference will not raise any safety or effectiveness issue.

Remark 4:

The power supply of subject device is d.c. 4.5 V, 3*AA batteries or AC adapter (INPUT: 100-240VAC 50/60HZ OUTPUT: 5V DC 1A), and the predicate device is 6V 1A, 4 × AA/1.5V (LR6) Alkaline batteries, or AC Adapter (Model: SINPRO, HPU15-102 Input: 100-240V AC 47-63Hz / Output: 5.99V, DC, 2A). They are internal power supply or AC power supply. The subject devices are compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30 and ISO 81060-1 standards. So the difference will not raise any safety or effectiveness issue.

Remark 5:

The intended arm circumferences of the proposed and predicate device are different. This difference is very slight, and the cuff size is appropriate to the claimed intended arm

9

001_510(k) Summary Version: 1.1

circumference per IEC 80601-2-30. Therefore, this point is considered as substantially equivalent.

Remark 6:

The time of automatic power off is 60s for subject device, but it is unknown for predicate device. This function is optional; it can be turned off by pressing "on/off' button, and the subject device is compliance with the IEC 80601-2-30 standard, so the difference will not raise any safety or effectiveness issue.

8. Discussion of Clinical Tests Performed:

Our blood pressure monitor and cuff have been conducted clinical testing to verify the accuracy according to ISO 81060-2: Third Edition 2018-11 Non-invasive sphygmomanometers- Part 2: Clinical investigation of intermittent automated measurement type. The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device C02 in the group of 90 subjects (42 male and 48 female, patient age between 17 to 74) with qualified distribution. There was not adverse effects ad complication during clinical testing. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.

9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

The subject device was tested to evaluate its safety and effectiveness, including the Following table:

Biocompatibility Testing:

The biocompatibility evaluation for the body-contacting component (cuff) was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Device - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The cuff has performed and passed the Biocompatibility test. So we have reason to believe that the cuff is safe for the users. The cuff complies with the following standards:

ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO 10993-5: 2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity

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001_510(k) Summary Version: 1.1

ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

Electrical and EMC Safety:

The electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1:2005, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-2:2014, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances -Requirements and tests

Performance:

The performance testing was performed to, and passed, the following standards:

IEC 80601-2-30:2018, Medical Electrical Equipment -- Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive

Sphygmomanometers

ISO 81060-2:2018, Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type

ISO 81060-1:2007, Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type

Software:

We have also conducted Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" and following standard:

IEC 62304:2015, Medical device software - Software life cycle processes

Other requirement:

The subject device was evaluated its usability and risks according to the following standards: ISO 14971:2007, Medical devices - Application of risk management to medical devices. (General)

IEC 62366-1:2015, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices

Summary:

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001_510(k) Summary Version: 1.1

Based on the above performance as documented in this application, the Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.

8.0 Conclusions

Blood pressure monitor, Model C02 and F01 have the same intended use and similar characteristics as the predicate device. Form the above information we conclude the subject device, C02 and F01 are substantially equivalent to the predicate devices, HL858CL which is manufactured by. Health & Life Co., Ltd. These conclude that any differences in their characteristics do not raise any safety and effectiveness issues.

9.0 Summary prepared date

May 15, 2020