Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor

K212115 · Joytech Healthcare Co. , Ltd. · DXN · Jan 5, 2022 · Cardiovascular

Device Facts

• Record ID: K212115
• Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
• Applicant: Joytech Healthcare Co. , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age. The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

Device Story

Fully automatic digital blood pressure monitors (arm and wrist-type) utilize oscillometric method to measure systolic/diastolic pressure and pulse rate. Device uses integral piezoelectric pump for cuff inflation and electric solenoid valve for deflation. Microprocessor-based software analyzes pulse waveform data extracted during inflation. Features include irregular heartbeat detection (warning if pulse interval difference >25%), body movement detection, and cuff loose detection. Devices operate as standalone units or connect via 2.4GHz BLE to 'JoyHealth' mobile app for trend visualization. Intended for OTC use in home/clinical environments by patients or clinicians. Output displayed on LCD; data transmitted to paired terminal. App provides trend graphs but no diagnostic/medical interpretation. Benefits include convenient, non-invasive blood pressure monitoring for hypertension management.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2018+AMD2020. Arm-type study: 85 patients (46 female, 39 male). Wrist-type study (Model DBP-8278B): 85 patients (43 female, 42 male). Wrist-type study (Model DBP-8276H): 85 patients (41 female, 44 male). All studies used same-limb sequential method against manual mercury sphygmomanometer reference. Results confirmed accuracy within ISO 81060-2 limits; no adverse events or side effects reported.

Technological Characteristics

Oscillometric measurement; piezoelectric pump; solenoid valve; ABS housing; biocompatible cuff materials (ISO 10993-5/10). Connectivity: 2.4GHz BLE (V5.0). Power: AAA batteries or AC adapter (2MOPP); select models use rechargeable lithium (IEC 62133-2). Standards: AAMI/ANSI/IEC 80601-2-30, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2. Software: Microprocessor-based algorithm for oscillometric analysis.

Indications for Use

Indicated for adults and adolescents over 12 years of age for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in home or clinical settings.

Regulatory Classification

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.

Predicate Devices

• H-BP100SBP (K161886)
• BP6100 (K182127)
• BP4350 (K182166)

Submission Summary (Full Text)

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Jan 5, 2022

Joytech Healthcare Co.,ltd Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city Hangzhou, Zhejiang 311100 China

Re: K212115

Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital 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 27, 2021 Received: December 7, 2021

Dear Ren Yunhua:

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.

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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 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.

for

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

Enclosure

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### Indications for Use

510(k) Number (if known) K212115

#### Device Name

Fully Automatic Digital Blood Pressure Monitor Including Arm-type: DBP-6179, DBP-6173, DBP-6173, DBP-6273B, DBP-6175, DBP-6277B, DBP-6177, DBP-6181, DBP-6281B, DBP-6182, DBP-6282B, DBP-6185, DBP-6285B, DBP-6186, DBP-6286B, DBP-6191 Wrist-type: DBP-8276H, DBP-8176H, DBP-8278B, DBP-8178, DBP-8288B, DBP-8188, DBP-8189

Indications for Use (Describe)

The Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

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

□ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.

# 510(k) Summary

The assigned 510(k) number is:

K212115

## 2.1 Subiectter's Identification:

Name: JOYTECH Healthcare Co., Ltd.

Add.: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100

Zhejiang, China.

Contact Person: Yunhua Ren

Phone: [phone]

Fax: [phone]

Email: [e-mail]

## 2.2 Name of the Device:

Trade Name: Fully Automatic Digital Blood Pressure Monitor

| Arm-type | DBP-6279B, DBP-6179, DBP-6173, DBP-6273B, DBP-6275B, DBP-6175,<br>DBP-6277B, DBP-6177, DBP-6181, DBP-6281B, DBP-6182, DBP-6282B,<br>DBP-6185, DBP-6285B, DBP-6186, DBP-6286B, DBP-6191 |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wrist-type | DBP-8276H, DBP-8176H, DBP-8278B, DBP-8178, DBP-8288B, DBP-8188,<br>DBP-8189 |

#### Common Name: Blood Pressure Monitor

Classification name: Non-invasive blood pressure measurement System

21 CFR 870-1130, Class II, 74-DXN.

## 2.3 Classification Information:

Regulation Number: 870.1130

Product Code: DXN

Device Class: II

Panel: 74 Cardiovascular

# 2.4 Predicate Device Information:

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Image /page/4/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text "JOYTECH" is in blue, with a red arrow pointing to the right above the "O" and "Y". The "I" is red. To the right of "JOYTECH-I" is Chinese text in blue.

The Arm-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following predicate device:

| 510(k) number | Predicate device model | Product code | Manufacturer |
|---------------|------------------------|--------------|-----------------------------------------------------|
| K161886 | H-BP100SBP | DXN | Guangdong Transtek Medical Electronics Co.,<br>Ltd. |

The Wrist-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following prdicate devices:

| 510(k) number | Predicate device model | Product code | Manufacturer |
|---------------|------------------------|--------------|----------------------------|
| K182127 | BP6100 | DXN | OMRON HEALTHCARE Co., Ltd. |
| K182166 | BP4350 | DXN | OMRON HEALTHCARE Co., Ltd. |

## 2.5 Device Description:

The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.

The pulse rate measurement is compare 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 heartbeat when the difference of the time intervals is over 25%.

Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of

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measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.

Unlimited readings can be stored in the app for archiving and review by the user.

The detail comparisons among the Arm-Type series are listed in table below:

| Features<br>Models | A | B | C | D | E | F | G | H | I (mm) | J<br>(cm) | K(mm) | L | M | N | O | P | Q | R | S | T |
|--------------------|---|---|------------------|---|---|---|---|---|-----------------|-----------|-----------|---|---|---|---|---|---|---|---|---|
| DBP-6179 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 142.5*107.2*44 | 22-36 | 112*62 | O | O | N | N | N | N | O | Y | Y |
| DBP-6279B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 142.5*107.2*44 | 22-36 | 112*62 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6173 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 142.5*107.2*44 | 22-36 | 95.5*54.5 | O | O | N | N | N | N | O | Y | Y |
| DBP-6273B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 142.5*107.2*44 | 22-36 | 95.5*54.5 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6175 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 128*130*144 | 22-36 | 118*65 | O | O | N | N | N | N | O | Y | Y |
| DBP-6275B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 128*130*144 | 22-36 | 118*65 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6177 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 149.8*80.4*45.7 | 22-36 | 83.1*53.1 | O | O | N | N | N | N | O | Y | Y |
| DBP-6277B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 149.8*80.4*45.7 | 22-36 | 83.1*53.1 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6181 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 155.5*108.5*75 | 22-36 | 87.5*85 | O | O | N | N | N | N | O | Y | Y |
| DBP-6281B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 155.5*108.5*75 | 22-36 | 87.5*85 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6182 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | N | N | O | Y | Y |
| DBP-6282B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6185 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | N | N | O | Y | Y |
| DBP-6285B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6186 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | N | N | O | Y | Y |
| DBP-6286B | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 150*108*65 | 22-36 | 87.5*85 | O | O | N | N | Y | N | O | Y | Y |
| DBP-6191 | Y | O | 60<br>Memories×2 | Y | N | Y | Y | Y | 136*94.5*57 | 22-36 | 50*62 | O | O | N | N | N | N | O | Y | Y |

A = Powered by 3 AAA size batteries

- B= Powered by AC adaptor
- C = Memory Size
- D = Time & Date
- E = Results Average in Three way
- F = WHO (World Health Organization) Classification Indicator

G = Last 3 Results Average

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Image /page/6/Picture/0 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text is in a sans-serif font. The logo is for a company that specializes in technology.

H = Irregular Heartbeat Detection I = Outside Demission (L x W x H in unit mm) J = Cuff Size K = LCD Size (Viewing Area in unit mm) L = LCD Backlight M= Voice N= PC connecter O=Music P=Bluetooth Function Q=mmHg/kPa Switchable R=Beep buzzer S= Cuff Loose Detection T= Arm Shake Detection Note: Y= Yes N = No O= Optional function depending on clients' needs

The detail comparisons among the Wrist-Type series are listed in table below:

| Features<br>Models | A | B | C | D | E | F | G | H (mm) | I (cm) | J(mm) | K | L | M | N | O | P | Q | R | S | T |
|--------------------|---|---------------|---|---|---|---|---|------------|-----------|---------|---|---|---|---|---|---|---|---|---|---|
| DBP-8176H | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 62*55.2*19 | 13.5-21.5 | 34*34.6 | Y | N | N | N | N | Y | O | Y | N | O |
| DBP-8276H | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 62*55.2*19 | 13.5-21.5 | 34*34.6 | Y | N | N | Y | N | Y | O | Y | N | O |
| DBP-8178 | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 73*66*27.5 | 13.5-21.5 | 44*42 | O | O | N | N | N | O | O | Y | N | N |
| DBP-8278B | Y | 60 Memories×2 | Y | Y | Y | N | Y | 73*66*27.5 | 13.5-21.5 | 44*42 | O | O | N | Y | N | O | O | Y | N | N |
| DBP-8188 | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 84*62*25 | 13.5-21.5 | 43.7*40 | O | O | N | N | N | O | O | Y | N | N |
| DBP-8288B | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 84*62*25 | 13.5-21.5 | 43.7*40 | O | O | N | Y | N | O | O | Y | N | N |
| DBP-8189 | Y | 60 Memories×2 | Y | Y | Y | Y | Y | 84*62*23.6 | 13.5-21.5 | 32*40.5 | O | N | N | N | N | Y | O | Y | N | N |

Note: DBP-8276H, DBP-8176H are equipped with lithium battery. Other models equipped with alkaline battery.

A = Powered by AAA Batteries / Lithium battery

(DBP-8276H, DBP-8176H equipped with rechargeable lithium battery)

- B= Memory Size
- C= Time & Date
- D = WHO (World Health Organization) Classification Indicator
- E = Last 3 Results Average
- F = Irregular Heartbeat Detection
- G = Low Voltage detection
- H= Outside Dimension (L x W x H in unit mm)
- I = Cuff Size
- J = LCD Size (Viewing Area in unit mm)
- K= LCD Backlight
- L= Voice
- M= PC connecter
- N=Bluetooth function
- O=mmHg/kPa Switchable
- P=Beep buzzer
- Q=Heart Zone indicator

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Image /page/7/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.

R= Arm Shake indicator S= Cuff Loose indicator T=Powered by AC adaptor Note: Y= Yes N = No O= Optional function depending on clients' needs

The devices are all designed and manufactured according to AAMI/ANSV/IEC80601-2-30:2018, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

#### 2.6 Intended Use:

The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

#### 2.7 Comparison of Technological Characteristics with predicate device:

#### 2.7.1 Arm-type

The arm-type blood pressure monitor manufactured by JOYTECH have the same arm cuff type, features and specifications with the Welch Allyn blood pressure monitor H-BP100SBP which 510k number is K161886, therefore we choose the device act as the predicate device. The detail comparison of technical characteristic as below:

| Comparison item | Subject device in present application | Predicate device K161886 (model:H-BP100SBP) | Comparison result / Explanation |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| The trade name | Arm-type Fully Automatic<br>Digital Blood Pressure Monitor | Welch Allyn Blood Pressure<br>Device | / |
| Manufacturer | JOYTECH Healthcare Co.,<br>Ltd. | Guangdong Transtek Medical<br>Electronics Co., Ltd | / |
| Recommended<br>classification<br>regulation | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | Identical |
| Regulatory class | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | Identical |
| Indication for use | The Arm-type Fully Automatic | Welch Allyn Blood Pressure | Similar |
| | | | |
| | Blood Pressure Monitors are<br>intended to measure blood<br>pressure (systolic and diastolic)<br>and pulse rate of adults and<br>adolescents over 12 years of<br>age. | Device H-BP100SBP is digital<br>monitor intended for use in<br>measuring blood pressure and<br>heartbeat rate in adult patient<br>population with arm<br>circumference ranging from 15<br>cm to 54 cm (about 6-21 inches).<br>These devices detect the<br>appearance of irregular<br>heartbeats during measurement<br>and give a warning signal with<br>readings. | Note1 |
| Measuring<br>principle | Oscillometric method | Oscillometric method | Identical |
| Measurement<br>type | Determined during inflation | Determined during inflation | Identical |
| Cuff location | Upper arm | Upper arm | Identical |
| Specification | | | |
| Measuring range | Systolic Pressure: 60mmHg ~<br>260 mmHg<br>Diastolic Pressure:<br>30mmHg~200 mmHg<br>Pulse:30~180 Beats/Minute | Systolic Pressure: 50mmHg ~<br>260 mmHg<br>Diastolic Pressure:<br>25mmHg~220 mmHg<br>Pulse:40~199 Beats/Minute | Similar.<br>Note2 |
| Max cuff pressure | 299 mmHg | 300mmHg | Similar |
| Accuracy | Static Pressure: $\pm$ 3mmHg<br>Pulse: $\pm$ 5% | Pressure: $\pm$ 0.4kPa (3mmHg)<br>Pulse value: $\pm$ 5% | Identical |
| Inflation | By air pump | By air pump | Identical |
| Pressure release | By solenoid valve | By solenoid valve | Identical |
| Operating<br>Temp. &<br>humidity | Temp.: 10℃~40℃<br>Humidity: 15~93%RH<br>Atmospheric:<br>800hPa~1060hPa | Temp.:5℃~40℃<br>Relative humidity 85%RH<br>Atmospheric<br>pressure:86kPa to 106kPa | Similar<br>Note 3 |
| Storage Temp.<br>& humidity | Temp.: -25℃~55℃<br>Humidity:<br>$\le$ 93% RH | Temp.:-20℃~60℃<br>Relative Humidity:<br>10% RH - 93% RH<br>Atmospheric<br>Pressure: 50kPa to<br>106 kPa | Similar<br>Note 4 |
| Cuff<br>circumference | Fits arm circumference 22-36<br>cm | The three preformed cuff units,<br>which are<br>applicable to arm circumference<br>between 15-24cm, 22-42cm and<br>40-54cm to meet different<br>Population's need. | Similar.<br>Note 5 |
| Supply<br>power<br>source | 3x1.5V AAA battery or 2MOPP<br>Medical AC adaptor (DC 5V,<br>1A, recommend but not<br>provide) | powered by four AA alkaline<br>batteries or by a AC adapter (DC<br>6V,1A)(not include) | Similar<br>The different in the<br>specification is<br>documented<br>and tested |
| PCB or Electrical<br>scheme | BP73PCB<br>BP75PCB | Unknown | Similar<br>The different in the |
| | BP77PCB<br>BP81PCB<br>BP91PCB | | specification is<br>documented and tested |
| Display<br>component | 1.Device LCD;<br>2.iOS device or Android device | 1.Device LCD;<br>2.iOS device or Android device | Identical |
| Bluetooth<br>Module version | V5.0 | V4.0 | Similar.<br>Note6 |
| System<br>requirement | Bluetooth 4.0 or later/<br>Android 5.0 or later/<br>IOS 9.0 or later | Platform which support<br>Bluetooth 4.0 technology | Similar<br>Note 7 |
| Bluetooth<br>features | Transmit data to<br>smart phone via<br>Bluetooth | Transmit data to<br>smart phone via<br>Bluetooth | Identical |
| Function on APP | Storage test result/<br>Announce test result/ Read<br>memories in App/ Empty<br>memories in App/ Draw curve/<br>Set the personal<br>information in app | Unknown | Different.<br>Note8 |
| Wireless<br>communication | Frequency range: 2.4 GHz<br>(2400 - 2483.5 MHz)<br>Modulation type: GFSK<br>Antenna gain: 0.5dBi | Frequency range: 2.4 GHz (2402<br>- 2480 MHz)<br>Modulation type: GFSK<br>Antenna gain: 0dBi | Equivalent<br>The difference have<br>verified by FCC test. |
| Sterilization | Not applicable | Not applicable | Identical |
| Features<br>Irregular<br>heart<br>beat | Irregular heart beat is displayed<br>on the LCD. | Irregular heart beat is displayed<br>on the LCD. | Identical |
| Blood<br>Pressure<br>categories | WHO classification | Blood pressure high and low<br>distinguish | Similar<br>Note9 |
| Arm<br>shake<br>indicator | Yes | Yes | Identical |
| Cuff<br>loose<br>indicator | Yes | None | Different.<br>Note10 |
| Memory | 2*60 Memories in Two Groups<br>with Date and Time | Have memory function | Similar.<br>Note11 |
| Material | ABS for the case and plastic<br>foil for the labels of the device.<br>Bio-compatibility materials are<br>used for the applied parts (Cuff<br>containing a interal bladder) | ABS is used to outer housing of<br>the main unit. | Similar.<br>Note12 |

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Image /page/8/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters.

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Image /page/9/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, with a red triangle above the "O". To the right of "JOYTECH" are some Chinese characters in blue.

Notel: The intended use of subject device and predicate device are the same. The clinical accuracy of subject device applied to adolescents over 12 years of age population have been verified and validation , which comply with the requirements of ISO 81060-2. And the clinical safety also have been validated as for without any AE or side-effect in clinical investigation.

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Image /page/10/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text "JOYTECH-I" is in English, and there are three Chinese characters to the right of the English text.

Note2: The measuring range of the subject device have been verified by IEC60601-1 and IEC 80601-2-30 standard test.

Note3: The operation environment of the subject device have been verified by IEC 60601-2-30 standard test.

Note4: The storage environment of the subject device have been verified by IEC 60601-1 and IEC 80601-2-30 standard test.

Note5: The safety and effective for fits arm circumference 22-36cm of subject device have been verified and validation by bench test according to IEC 60601-1-11 and IEC 80601-2-30. Meanwhile, the clinical accuracy of cuff size 22-36cm have been validation according to the ISO 81060-2:2018, which cannot raise new safety and effective issue.

Note 6: The subject device adopt new BT version and it could compatible for BT 4.0. The cybersecurity risk has been considered and the overall residual risk is acceptable.

Note7: All over of subject models have passed FCC, EN301489-17, EN 300328 and wireless coexistence test.

Note8: The change in the specification is documented, and the cybersecurity risk has been considered and the overall residual risk is acceptable. The change does not affect the intended use or the fundamental scientific technology.

Note9: The blood pressure WHO classification function have been verified by software verified and validation report.

Note10: The cuff loose indicator function of subject device have been verified and validation through Software verified and validation report. And this function adding cannot bring new risks.

Note 11: The quantity of storage readings is different between the subject device and predicate device. The change in the specification is documented, and The change does not affect the intended use or the fundamental scientific technology.

Note12:The materials of cuff from subject device have been tested and found to comply with requirements of ISO 10993-5: 2009 and ISO 10993-10:2010, which cannot result in cytotoxicity, sensitization or intracutaneous reacticity.

#### 2.7.2 Wrist-type

The wrist-type blood pressure monitor manufactured by JOYTECH have the same wrist cuff type, features and specifications with the Omron wrist blood pressure monitor BP6100 which 510k number is K182127, therefore we choose the device act as the predicate device. While BP6100 model has no bluetooth function, Omron wrist blood pressure monitor BP4350 (K182166) was chosen to be predicate device 2 with bluetooth function. The detail comparison of technical characteristic as below:

| Comparison<br>item | Subject device in<br>present application | Predicate device 1<br>K182127 | Predicate device 2<br>K182166 | Comparison<br>result / |
|--------------------|------------------------------------------|-------------------------------|-------------------------------|------------------------|
|--------------------|------------------------------------------|-------------------------------|-------------------------------|------------------------|

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Image /page/11/Picture/0 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text is in a sans-serif font.

| | | (Model:BP6100) | (Model: BP4350) | Explanation |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| The trade name | Wrist-type<br>Automatic<br>Blood<br>Pressure<br>Monitor | Wrist Blood Pressure<br>Monitor Model BP6100 | Wrist Blood Pressure<br>Monitor Model BP4350 | / |
| Manufacturer | JOYTECH<br>Healthcare Co., Ltd. | OMRON HEALTHCARE<br>Co., Ltd | OMRON<br>HEALTHCARE Co., Ltd | / |
| Recommended<br>classification<br>regulation | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure<br>Measurement<br>System | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | 21CFR 870.1130,<br>Noninvasive Blood<br>Pressure Measurement<br>System | Identical |
| Regulatory<br>class | II | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | DXN | Identical |
| Indication for<br>use | The Fully Automatic<br>Blood Pressure<br>Monitors are<br>intended to measure<br>blood pressure<br>(systolic and<br>diastolic) and pulse<br>rate of adults and<br>adolescents over 12<br>year of age. | The device is a digital<br>monitor intended for use<br>in measuring blood<br>pressure and pulse<br>rate in adult patient<br>population with wrist<br>circumference ranging<br>from 5.3 inches to<br>8.5 inches (13.5 cm to<br>21.5 cm).<br>The device detects the<br>appearance of irregular<br>heartbeats during<br>measurement and gives a<br>warning signal with<br>readings. | The device is a digital<br>monitor intended for use<br>in measuring blood<br>pressure and pulse<br>rate in adult patient<br>population with wrist<br>circumference ranging<br>from 5.3 inches to 8.5<br>inches (13.5cm to<br>21.5cm). The device<br>detects the appearance of<br>irregular heartbeats<br>during measurement and<br>gives a warning signal<br>with readings. | Similar<br>Note1 |
| Measuring<br>principle | Oscillometric<br>method | Oscillometric method | Oscillometric method | Identical |
| Measurement<br>type | Determined during<br>inflation | Determined during<br>inflation | Determined during<br>inflation | Identical |
| Cuff location | Wrist | Wrist | Wrist | Identical |
| Specification | | | | |
| Measuring<br>range | Systolic Pressure:<br>60mmHg~260<br>mmHg<br>Diastolic Pressure:<br>30mmHg~200<br>mmHg<br>Pulse:30~180<br>Beats/min | Systolic Pressure:<br>60mmHg~260 mmHg<br>Diastolic Pressure:<br>40 mmHg~215 mmHg<br><br>Pulse:40~180 Beats/min | Systolic Pressure:<br>60mmHg~260 mmHg<br>Diastolic Pressure:<br>40 mmHg~215 mmHg<br><br>Pulse:40~180 Beats/min | Similar.<br>Note 2 |
| Max<br>pressure | cuff 299 mmHg | 299 mmHg | 299 mmHg | Identical |
| | | | | |
| circumference | circumference 13.5-<br>21.5cm | 13.5-21.5cm | 13.5-21.5cm | |
| Accuracy | Static Pressure: ±<br>3mmHg<br>Pulse: ± 5% | Static Pressure: ± 3mmHg<br>Pulse: ± 5% of display<br>reading | Static Pressure: ±<br>3mmHg<br>Pulse: ± 5% of display<br>reading | Identical |
| Inflation | By air pump | By air pump | By air pump | Identical |
| Pressure release | By solenoid valve | By solenoid valve | By solenoid valve | Identical |
| Operating<br>Temp. &<br>humidity | Temp.: 10°C~40°C<br>Humidity:<br>15~93%RH<br>Atmospheric:<br>800hPa~1060hPa | Temp.: 10°C~40°C<br>Humidity: 15~90%RH<br>Atmospheric:<br>800hPa~1060hPa | Temp.: 10°C~40°C<br>Humidity: 15~90%RH<br>Atmospheric:<br>800hPa~1060hPa | Similar<br>Note 3 |
| Storage Temp.<br>& humidity | Temp.: -25°C~55°C<br>Humidity:<br>≤93% RH | Temp.:-20°C~60°C<br>Relative Humidity:<br>10% RH - 90% RH<br>Atmospheric | Temp.:-20°C~60°C<br>Relative Humidity:<br>10% RH - 90% RH<br>Atmospheric | Similar<br>Note 4 |
| Supply<br>power<br>source | For models DBP-<br>8178, DBP-8278B,<br>DBP-8188, DBP-<br>8288B, DBP-8189:<br>2x1.5V AAA battery<br>DBP-8276H and<br>DBP-8176H are<br>powered by 3.7 V<br>rechargeable lithium<br>battery or 2MOPP<br>Medical AC adaptor<br>(DC 5V,1A,<br>recommend but not<br>provide ) | Two "AAA" batteries 1.5v | Two "AAA" batteries<br>1.5v | Similar.<br>Note 5 |
| Display<br>component | 1.Device LCD;<br>2.iOS device or<br>Android device | Device LCD | 1.Device LCD;<br>2.iOS device or Android<br>device | Identical<br>to<br>predicate<br>device 2. |
| Bluetooth<br>Module version | V5.0 | None | Unknown | Note 6 |
| Wireless<br>communication | Frequency range: 2.4<br>GHz (2400 - 2483.5<br>MHz)<br>Modulation type:<br>GFSK<br>Antenna gain:<br>0.5dBi | None | Frequency range: 2.4<br>GHz (2400 - 2483.5<br>MHz)<br>Modulation: GFSK<br>Effective radiated power:<br>< 20 dBm | Equivalent<br>The<br>difference<br>have been<br>verified by<br>FCC test. |
| Bluetooth<br>features | Transmit data to<br>smart phone via<br>Bluetooth | None | Transmit data to<br>smart phone via<br>Bluetooth | Identical<br>to<br>the predicate<br>device 2. |
| Function on<br>APP | Storage test result/<br>Announce test result/<br>Read memories in<br>App/ Empty<br>memories in App/ | None…