(177 days)
Not Found
No
The device description mentions "software algorithms within the microprocessor" for analyzing waveform data, but there is no mention of AI, ML, or related concepts like neural networks, deep learning, or training/test sets for such algorithms. The app's functionality is limited to displaying trend graphs, not analysis or interpretation.
No
A therapeutic device is used to treat or alleviate a disease or condition. This device is described as measuring blood pressure and pulse rate, which are diagnostic measurements, not treatments.
No
The device measures blood pressure and pulse rate and can indicate irregular heartbeat. However, the accompanying app explicitly states it "does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making." This indicates the device itself is for information gathering, not for making a medical diagnosis.
No
The device description clearly states it is a "Fully Automatic Digital Blood Pressure Monitor" which is a physical device with components like a cuff, pump, valve, and microprocessor. While it uses software algorithms and can connect to an app, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: This device measures blood pressure and pulse rate directly from the patient's arm or wrist using a non-invasive method (oscillometric). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) of the patient, not to perform diagnostic tests on biological samples.
- Device Description: The description details a physical measurement process involving a cuff, pump, and sensor, not the analysis of biological specimens.
- Lack of IVD-related terms: There is no mention of reagents, assays, sample types, or laboratory procedures, which are typical of IVD devices.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 with circumference ranging from 22cm to 36cm or 22cm to 42cm or 32cm to 48cm.
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 with circumference ranging from 13.5cm to 21.5cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, Wrist
Indicated Patient Age Range
adults and adolescents over 12 years of age.
Intended User / Care Setting
Home and clinical environment, Over-The-Counter Use
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)
Clinical Validation:
ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers --Part 2: Clinical investigation of intermittent automated measurement type.
Arm-type:
For 22cm36cm, we cite the clinical investigation report of K212115.42cm, we use a clinical investigation report from another submission. In this report, there are 88 patients (47females and 41 males) with cuff 22cm~42cm participated in the clinical study.
For 22cm
For 32cm-48cm, Model DBP-6279B was selected as representative for testing. 85 patients (36 females and 49 males) participated in the clinical study.
Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.
Wrist-type:
For Wrist-type blood pressure monitor of 10 Models only with one cuff size of 13.5cm~21.5cm. we cite the clinical investigation report of K212115.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Static 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.
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2023
Joytech Healthcare Co.,Ltd Yunhua Ren, General Manager No.365. Wuzhou Road Yuhang Economic Development Zone, Hangzhou City Hangzhou, Zhejiang 311100 China
Re: K230566
Trade/Device Name: Arm-tvpe 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: July 27, 2023 Received: July 27, 2023
Dear Yunhua Ren:
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Robert T. Kazmierski -S
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
2
Indications for Use
510(k) Number (if known) K230566
Device Name Fully Automatic Digital Blood Pressure Monitor Including Arm-type: DBP-61A0, DBP-62A1B, DBP-62A2B, DBP-61A3, DBP-61A3B, DBP-61A4, DBP-62A4B, DBP-6194, DBP-6294B, DBP-6195, DBP-6295B, DBP-6196, DBP-6296B; Wrist-type: DBP-81A5, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8198, DBP-8298B, DBP-8199, DBP-8299B: Indications for Use (Describe)
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 vears of age with circumference ranging from 22cm to 22cm to 42cm or 32cm to 48cm.
The Wrist-type 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 with circumference ranging from 13.5cm.
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 JOYTEC-I. The logo is in blue and red. The text "JOYTEC-I" is in blue, except for the "I", which is in red. To the right of the text is a Chinese word in blue.
510(k) Summary
The assigned 510(k) number is:
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: +86-571-81957767
Fax: +86-571-81957750
Email: renyh@sejoy.com
2.2 Name of the Device:
Trade Name: Fully Automatic Digital Blood Pressure Monitor
| Arm-type | DBP-61A0, DBP-62A1B, DBP-61A2, DBP-62A2B, DBP-61A3,DBP-62A3B, DBP-
61A4, DBP-62A4B, DBP-6194, DBP-6294B, DBP-6195, DBP-6295B, DBP-6196,
DBP-6296B, SBM53, DBP-6279B,DBP-6179, DBP-6273B, DBP-6173 |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wrist-type | DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-
8198, DBP-8298B, DBP-8199, DBP-8299B |
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. The logo is in blue and red. To the right of the word JOYTECH are some Chinese characters.
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 |
|---------------|---------------------------|--------------|------------------------------|
| K212115 | DBP-6279B | DXN | JOYTECH Healthcare Co., 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 |
|---|---|---|---|
| K212115 | DBP-8278B | DXN | JOYTECH 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 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.
5
Unlimited readings can be stored in the app for archiving and review by the user.
The all models of this application are DBP-61A0, DBP-62A1B, DBP-61A2, DBP-62A2B, DBP-61A3,DBP-62A3B,DBP-61A4,DBP-62A4B,DBP-6194,DBP-6294B,DBP-6195,DBP-6295B,DBP-6196, DBP-6296B, SBM53, DBP-6279B,DBP-6179, DBP-6273B, DBP-6173,DBP-81A5, DBP-82A5B, DBP-81A6, DBP-82A6B, DBP-8197, DBP-8297B, DBP-8298B, DBP-8199, DBP-8299B.
And DBP-6279B,DBP-6179, DBP-6273B, DBP-6173 already have 510k number of K212115. But now these models have changed specifications on cuff size and measuring range of diastolic Pressure.So we are applying for new 510K.
| Models
| Features | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-61A0 | 3*1.5V AAA or | |||||||||||||
| Adaptor | 1*30 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 98×90×61.8mm | Y | |
| DBP-62A1B | 3*1.5V AAA or | |||||||||||||
| Adaptor | 1*30 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 98×90×61.8mm | Y | |
| DBP-61A2 | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-62A2B | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-61A3 | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-62A3B | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-61A4 | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | N | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-62A4B | 4*1.5V AAA or | |||||||||||||
| Adaptor | 2*120 | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | 1249243mm | Y | |
| DBP-6194 | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 110.2101.957.3 | ||
| mm | Y | |||||||||||||
| DBP-6294B | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 110.2101.957.3 | ||
| mm | Y | |||||||||||||
| DBP-6195 | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 140.2103.351.1 | ||
| mm | Y | |||||||||||||
| DBP-6295B | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 140.2103.351.1 | ||
| mm | Y | |||||||||||||
| DBP-6196 | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 1039351mm | Y |
The detail comparisons among the Arm-Type series are listed in table below:
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Image /page/6/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text is in English and Chinese.
| Adaptor | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-6296B | 3*1.5V AAA or | |||||||||||||
| Adaptor | 2*150 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 1039351mm | Y | |
| SBM53 | 4*1.5V AAA | 2*120 | Y | N | Y | N | Y | N | N | Y | Y | Y | 125 X 95 X 44mm | Y |
| DBP-6279B | 3*1.5V AAA or | |||||||||||||
| adaptor; | 2*60 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 142.5 x 107.2 x | ||
| 44mm | Y | |||||||||||||
| DBP-6179 | 3*1.5V AAA or | |||||||||||||
| adaptor; | 2*60 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 142.5 x 107.2 x | ||
| 44mm | Y | |||||||||||||
| DBP-6273B | 3*1.5V AAA or | |||||||||||||
| adaptor; | 2*60 | Y | Y | Y | Y | Y | Y | N | Y | Y | Y | 142.5 x 107.2 x | ||
| 44mm | Y | |||||||||||||
| DBP-6173 | 3*1.5V AAA or | |||||||||||||
| adaptor; | 2*60 | Y | Y | Y | Y | Y | N | N | Y | Y | Y | 142.5 x 107.2 x | ||
| 44mm | Y |
A = Powered Source
B= Memory Size with Time & Date
C = WHO (World Health Organization) Classification Indicator
D = Last 3 Results Average
- E = Irregular Heartbeat Detection
- F = Arm Shake Detection
G = Cuff Loose Detection
- H = Bluetooth Function
- I = MAM fucntion
J = Voice
K = Backlight
L = LCD display
M= Size (Viewing Area in unit mm)
N= Cuff Size (22-36cm,22-42cm,32-48cm)
- Note:
- Y= Yes N = No
| Models | A | B | C | D | E | F | G | H | I | J | K | L | M | N |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Features | ||||||||||||||
| DBP-81A5 | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-82A5B | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-81A6 | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-82A6B | 2*1.5V AAA | 2*100 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 86 $\times$ 64 $\times$ 30mm | Y |
| DBP-8197 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8297B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8198 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 82.3 $\times$ 63.8 $\times$ 27.5mm | Y |
| DBP-8298B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 82.3 $\times$ 63.8 $\times$ 27.5mm | Y |
| DBP-8199 | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | N | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
| DBP-8299B | 2*1.5V AAA | 2*150 | Y | Y | Y | Y | N | Y | N | Y | Y | Y | 83 $\times$ 64 $\times$ 30.7mm | Y |
The detail comparisons among the Wrist-Type series are listed in table below:
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Image /page/7/Picture/0 description: The image shows the text 'K230566' in a simple, sans-serif font. The text is presented in a straightforward manner, with each character clearly legible. The black text stands out against the white background.
Image /page/7/Picture/1 description: The image shows the logo for JOYTECH. The logo is in blue and red. The text "JOYTECH" is in blue, except for the "T", which is in red. There are some Chinese characters to the right of the text.
A = Powered Source B= Memory Size with Time & Date C = WHO (World Health Organization) Classification Indicator D = Last 3 Results Average E = Irregular Heartbeat Detection F = Arm Shake Detection G = Cuff Loose Detection H = Bluetooth Function I = MAM function J = Voice K = Backlight L = LCD display M= Size (Viewing Area in unit mm) N= Cuff Size (13.5-21.5cm) Note: Y= Yes N = No
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 Indication for use/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 with circumference ranging from 22cm to 36cm or 22cm to 42cm or 32cm to 48cm.
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 with circumference ranging from 13.5cm to 21.5cm.
2.7 Comparison of Technological Characteristics with predicate device:
2.7.1 Arm-type
The arm-type blood pressure monitor manufactured by JOYTECH Healthcare Co., Ltd. have the same features and specifications with the JOYTECH blood pressure monitor DBP-6279B which 510k number is K212115, therefore we choose the device act as the predicate device. The detail comparison of technical characteristic as below:
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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.
| Comparison item | Subject device in present application | Predicate device K212115 (model: DBP-6279B) | Comparison result / Explanation | |
|---|---|---|---|---|
| The trade name | Arm-type Fully Automatic Digital Blood Pressure Monitor | Arm-type Fully Automatic Digital Blood Pressure Monitor | Identical | |
| Manufacturer | JOYTECH Healthcare Co., Ltd. | JOYTECH Healthcare Co., Ltd. | / | |
| Recommended classification regulation | 21CFR 870.1130, | |||
| Noninvasive Blood | ||||
| Pressure Measurement | ||||
| System | 21CFR 870.1130, | |||
| Noninvasive Blood | ||||
| Pressure Measurement | ||||
| 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 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 Arm-type Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age. | Identical | |
| Measuring principle | Oscillometric method | Oscillometric measurement | Identical | |
| Measurement type | Determined during inflation | Determined during inflation | Identical | |
| Cuff location | Upper arm | Upper arm | Identical | |
| Specification | ||||
| Measuring range | Systolic Pressure: 60mmHg ~ 260 mmHg | |||
| Diastolic Pressure:40mmHg ~ 200 mmHg | ||||
| Pressure: 0mmHg~299 mmHg | ||||
| Pressure: ±3mmHg | ||||
| Pulse:30~180 Beats/Minute | ||||
| Pulse: ±5% | Systolic Pressure: 60mmHg ~ 260 mmHg | |||
| Diastolic Pressure:30mmHg ~ 200 mmHg | ||||
| Pressure: 0mmHg~299 mmHg | ||||
| Pressure: ±3mmHg | ||||
| Pulse:30~180 Beats/Minute | ||||
| Pulse: ±5% | Similar, | |||
| The difference has tested with qualified results. | ||||
| Inflation | By air pump | By air pump | Identical | |
| Pressure release | By solenoid valve | By solenoid valve | Identical | |
| Operating Temp. & humidity | Temp.: 10°C~40°C | |||
| Humidity: 15~93%RH | ||||
| Atmospheric: | ||||
| 800hPa~1060hPa | Temp.: 10°C~40°C | |||
| Humidity: 15~93%RH | ||||
| Atmospheric: | ||||
| 800hPa~1060hPa | Identical | |||
| Storage Temp. & humidity | Temp.: -25°C~55°C | |||
| Humidity: |