Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it uses the "oscillometric method" to analyze signals and define blood pressure and pulse rate, which is a well-known, non-AI/ML technique. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The device is described as a monitor intended to measure and display blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.

Diagnostic

Yes

The device "is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time." Monitoring these vital signs to assess a patient's health status constitutes a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like an inflatable cuff, pressure sensor, and battery, indicating it is not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to "monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm". This is a measurement taken directly from the patient's body (in vivo), not from a sample of bodily fluid or tissue (in vitro).
Device Description: The device uses a non-invasive technique with an inflatable cuff wrapped around the upper arm and an electronic pressure sensor. This is a physical measurement, not a test performed on a sample.
Lack of IVD Indicators: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are characteristic of IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor performs a direct physiological measurement on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

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

DXN

Device Description

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

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

medical professionals 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

Not Found

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

The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances -Requirements and tests, 2014
IEC 60601-1-11, 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 [Including: Technical Corrigendum 1 (2011)]
IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type. (Cardiovascular)

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

Measuring accuracy:
Pressure: ± 3mmHg
Pulse: ±5%

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.

K153552, K172895

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

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

0

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 and 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.

July 12, 2020

Dongguan E-Test Technology Co., LTD % Cassie Lee, Manager Dongguan E-Test Technology Co., Ltd Room 201, 301. Building 1, Changping Section No.1, Dongshen Road Dongguan City, Guangdong, China 523588

Re: K193627

Trade/Device Name: Automatic Upper 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: December 24, 2019 Received: December 26, 2019

Dear Cassie Lee:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 mediation-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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Indications for Use

510(k) Number (if known) K193627

Device Name

Automatic Upper Arm Blood Pressure Monitor

Indications for Use (Describe)

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

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

510(k) Summary

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

1. Submitter's Information

510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD

Establishment Registration Number: Applying

Address: Room 201,301. Building 1, Changping Section No.1,Dongshen Road, Changping

Town, Dongguan City, Guangdong, China.

Tel: +86-0769-81158038

Contact Person (including title): Victor Wan (Vice-president)

E-mail: victor@agelh.com

Application Correspondent:

Contact Person: Ms. Cassie Lee

DONGGUAN E-TEST TECHNOLOGY CO., LTD

Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping

Town, Dongguan City, Guangdong, China.

Tel: +86-0769-81158038

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K193627

Email: requlatory @glomed-info.com

2. Subject Device Information

Type of 510(k): Traditional

Common Name: Noninvasive blood pressure measurement systems

Classification Name: System, Measurement, Blood-Pressure, Non-Invasive

Trade Name: Automatic Upper Arm Blood Pressure Monitor

Model Name: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X,

BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819

Review Panel: Cardiovascular

Product Code: DXN

Regulation Number: 870.1130

Regulatory Class: 2

3. Predicate Device Information

| Sponsor | Dongguan Ageless Health Industrial Co., Ltd
Dongguan Ageless Health Industrial Co., Ltd |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name
and Model | AGE Automatic Upper Arm Blood Pressure Monitor
Models: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X
AGE Automatic Upper Arm Blood Pressure Monitor
Models: BA-815, BA-816, BA-818, BA-819 |

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510(k) Number	K153552	K172895
Product Code	DXN	DXN
Regulation
Number	870.1130	870.1130
Regulation
Class	II	II

4. Device Description

Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.

5. Intended Use / Indications for Use

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

6

6. Test Summary

The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards:

◆ IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012
� IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances -Requirements and tests, 2014
IEC 60601-1-11, 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 [Including: Technical Corrigendum 1 (2011)]
� IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
� ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
� ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: � Clinical Validation of Automated Measurement Type. (Cardiovascular)

7. Comparison to predicate device and conclusion

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The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Upper Arm Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
Company	DONGGUAN E-TEST
TECHNOLOGY CO.,
LTD	Dongguan Ageless Health
Industrial Co., Ltd	Dongguan Ageless Health
Industrial Co., Ltd	--
Product Name	Automatic Upper Arm
Blood Pressure Monitor	AGE Automatic Upper
Arm Blood Pressure
Monitor	AGE Automatic Upper
Arm Blood Pressure
Monitor	--
Model Name	BA-801X, BA-802X, BA-
803X, BA-805X, BA-
806X, BA-811X, BA-
812X, BA-813X, BA-
821X, BA-822X, BA-
823X, BA-826X, BA-818,
BA-819	BA-801X, BA-802X, BA-
803X, BA-805X, BA-
806X, BA-811X, BA-
812X, BA-813X, BA-
821X, BA-822X, BA-
823X, BA-826X	BA-815, BA-816, BA-818,
BA-819	--
Classification
Name	System, Measurement,
Blood-Pressure, Non-
Invasive	System, Measurement,
Blood-Pressure, Non-
Invasive	System, Measurement,
Blood-Pressure, Non-
Invasive	SE
510(k) Number	K193627	K153552	K172895	--
Product Code	DXN	DXN	DXN	SE
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
Intended Use /
Indications for
Use	Automatic Upper Arm
Blood Pressure Monitor
is intended for use by
medical professionals or
at home to monitor and
display diastolic, systolic
blood pressure and pulse
rate on adult each time,
with an air cuff buckled
around one's arm
according to the
instruction in the user's
guide manual.	AGE Automatic Upper
Arm Blood Pressure
Monitor is intended for
use by medical
professionals or at home
to monitor and display
diastolic, systolic blood
pressure and pulse rate
on adult each time, with
an air cuff buckled around
one's arm according to
the instruction in the
user's guide manual.	AGE Automatic Upper
Arm Blood Pressure
Monitor is intended for
use by medical
professionals or at home
to monitor and display
diastolic, systolic blood
pressure and pulse rate
on adult each time, with
an air cuff buckled around
one's arm according to
the instruction in the
user's guide manual.	SE
Energy source	DC 6V (4 X AA
1.5V alkaline batteries)	DC 6V (4 X AA
1.5V alkaline batteries)	DC 6V (4 X AA
1.5V alkaline batteries)	SE
Design	Software	Same version software			SE
	hardware	Same version hardware
Material	ABS plastic, Nylon, Latex	ABS plastic, Nylon, Latex	ABS plastic, Nylon, Latex	SE
Measurement
Site	Upper Arm	Upper Arm	Upper Arm	SE
Measuring
range	Pressure: 0~280 mmHg
Pulse: 40~199
beats/minute	Pressure: 0~280 mmHg
Pulse: 40~199
beats/minute	Pressure: 0~280 mmHg
Pulse: 40~199
beats/minute	SE
Pressure
resolution	1 mmHg or 0.1kPa	1 mmHg or 0.1kPa	1 mmHg or 0.1kPa	SE
Measuring
accuracy	Pressure: ± 3mmHg	Pressure: ± 3mmHg	Pressure: ± 3mmHg	SE
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict
	Pulse: ±5%	Pulse: ±5%	Pulse: ±5%
Cuff
Circumference	There are 6 size:
size A: 17cm--22cm
(SMALL ADULT CUFF)
size B: 22cm--30cm
(ADULT CUFF-1)
size C: 24cm--34cm
(ADULT CUFF-2)
size D: 22cm--42cm (L-
LARGE ADULT CUFF)
size E: 30cm--42cm
(LARGE ADULT CUFF)
size F: 42cm--50cm
(EXTRA LARGE ADULT
CUFF)	size A: 17cm--22cm
(SMALL ADULT CUFF)
size B: 22cm--30cm
(ADULT CUFF-1)
size C: 24cm--34cm
(ADULT CUFF-2)
size D: 22cm--42cm (L-
LARGE ADULT CUFF)
size E: 30cm--42cm
(LARGE ADULT CUFF)
size F: 42cm--50cm
(EXTRA LARGE ADULT
CUFF)	For BA-815: 22-34 cm;
For BA-816: 28-42 cm;
For BA-818 and BA-819,
there are 6 size:
size A: 17cm--22cm
(SMALL ADULT CUFF)
size B: 22cm--30cm
(ADULT CUFF-1)
size C: 24cm--34cm
(ADULT CUFF-2)
size D: 22cm--42cm (L-
LARGE ADULT CUFF)
size E: 30cm--42cm
(LARGE ADULT CUFF)
size F: 42cm--50cm
(EXTRA LARGE ADULT
CUFF)	SE
Size and
Weight of
model BA-
801X	About 460g (not include
battery);
(L)115.0mm X
(D)103.0mm X (H)
67.5mm	About 460g (not include
battery);
(L)115.0mm X
(D)103.0mm X (H)
67.5mm	/	SE
Size and
Weight of
model BA-
802X	About 460g (not include
battery);
(L)115.0mm X
(D)103.0mm X (H)
67.5mm	About 460g (not include
battery);
(L)115.0mm X
(D)103.0mm X (H)
67.5mm	/	SE
Elements of	Subject Device	Predicate Device1	Predicate Device2	Verdict
Comparison
Size and
Weight of
model BA-
803X	About 460g (not include
battery)
(L)119.0mmX
(D)100.0mm X
(H)63.2mm	About 460g (not include
battery)
(L)119.0mmX
(D)100.0mm X
(H)63.2mm	/	SE
Size and
Weight of
model BA-
805X	About 460g (not include
battery)
(L) 118.3mm X
(D)100.0mm X
(H)62.9mm	About 460g (not include
battery)
(L) 118.3mm X
(D)100.0mm X
(H)62.9mm	/	SE
Size and
Weight of
model BA-
806X	About 460g (not include
battery)
(L) 146.0mm X
(D)113.0mm X
(H)66.0mm	About 460g (not include
battery)
(L) 146.0mm X
(D)113.0mm X
(H)66.0mm	/	SE
Size and
Weight of
model BA-
811X	About 460g (not include
battery)
(L) 144.0mm X
(D)113.0mm X
(H)67.0mm	About 460g (not include
battery)
(L) 144.0mm X
(D)113.0mm X
(H)67.0mm	/	SE
Size and
Weight of
model BA-
812X	About 460g (not include
battery)
(L) 113.5mm X
(D)92.0mm X (H)48.0mm	About 460g (not include
battery)
(L) 113.5mm X
(D)92.0mm X (H)48.0mm	/	SE
Size and
Weight of
model BA-
813X	About 460g (not include
battery)
(L) 115.3mm X
(D)92.0mm X (H)48.0mm	About 460g (not include
battery)
(L) 115.3mm X
(D)92.0mm X (H)48.0mm	/	SE
Elements of
Comparison	Subject Device	Predicate Device1	Predicate Device2	Verdict

Size and
Weight of
model BA-
821X	About 610g (not include
battery)
(L) 150.0mm X
(D)100.0mm X
(H)60.0mm	About 610g (not include
battery)
(L) 150.0mm X
(D)100.0mm X
(H)60.0mm	/	SE
Size and
Weight of
model BA-
822X	About 380g (not include
battery)
(L) 135.0mm X
(D)90.0mm X
(H)47.65mm	About 380g (not include
battery)
(L) 135.0mm X
(D)90.0mm X
(H)47.65mm	/	SE
Size and
Weight of
model BA-
823X	About 460g (not include
battery)
138.0mm X(D)95.0mm
X (H)67.0mm	About 460g (not include
battery)
138.0mm X (D)95.0mm X
(H)67.0mm	/	SE
Size and
Weight of
model BA-
826X	About 420g (not include
battery)
143.0mm X(D)115.0mm
X (H)57.0mm	About 420g (not include
battery)
143.0mm X (D)115.0mm
X (H)57.0mm	/	SE
Size and
Weight of
model BA-818	About 465g (not include
battery)
(L) 103.0mm X
(D)129.0mm X
(H)161.0mm	/	About 465g (not include
battery)
(L) 103.0mm X
(D)129.0mm X
(H)161.0mm	SE
Size and
Weight of
model BA-819	About 438g (not include
battery)
(L) 160.0mm X
(D)98.0mm X (H)55.0mm	/	About 438g (not include
battery)
(L) 160.0mm X
(D)98.0mm X (H)55.0mm	SE
Elements of	Subject Device	Predicate Device1	Predicate Device2	Verdict
Comparison
Inflation and
Deflation	Automatic	Automatic	Automatic	SE
Measuring
Method	Oscillometry	Oscillometry	Oscillometry	SE
Patient
Population	Adult	Adult	Adult	SE
Display	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	Blood Pressure (Systolic
and Diastolic), Pulse,
Date, Time, WHO BP
Classification Indicating
Bar, Low Battery Icon,
Heart Icon, Memory
Record Number	SE
Software
Version	V01	V01	V01	SE
Operation
condition	Temperature: 5°C ~
40°C
Humidity: 15~90%RH
Atmospheric Pressure:86
kPa~106 kPa	Temperature: 5°C ~ 40°C
Humidity: 15~90%RH
Atmospheric Pressure:86
kPa~106 kPa	Temperature: 5°C ~ 40°C
Humidity: 15~90%RH
Atmospheric Pressure:86
kPa~106 kPa	SE
Transport/stora
ge environment	Temperature: -20°C ~
+65°C
Humidity: 10~95%RH
Atmospheric Pressure:86
kPa~106 kPa	Temperature: -20°C ~
+65°C
Humidity: 10~95%RH
Atmospheric Pressure:86
kPa~106 kPa	Temperature: -20°C ~
+65°C
Humidity: 10~95%RH
Atmospheric Pressure:86
kPa~106 kPa	SE
Safety	IEC 60601-1
IEC 60601-1-11	IEC 60601-1
IEC 60601-1-11	IEC 60601-1
IEC 60601-1-11	SE
Elements of	Subject Device	Predicate Device1	Predicate Device2	Verdict
Comparison
	IEC 80601-2-30	IEC 80601-2-30	IEC 80601-2-30
EMC	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	SE
Biocompatibility	ISO 10993 series	ISO 10993 series	ISO 10993 series	SE

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Comparison in Detail(s):

Final Conclusion:

The subject device noninvasive sphygmomanometer (Automatic Upper Arm Blood Pressure Monitor) (Model: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

All hardware and software of the subject device are based on that of the predicate device K 153552 and K 172895 since no new testing is presented in the submission.

Date of the summary prepared: July 8, 2020