(130 days)
Not Found
No
The description details standard oscillometric blood pressure measurement, irregular heartbeat detection based on simple thresholds, averaging of readings, and WHO classification lookup. There is no mention of AI or ML algorithms for data analysis, pattern recognition beyond simple thresholds, or predictive capabilities.
No
The device is a blood pressure monitor used for measurement and monitoring, not for treating a condition.
Yes
Explanation: The device measures blood pressure and heart rate, and specifically detects and indicates "Irregular Heart Beat (IHB)," which provides information about the physiological state of the patient beyond just a standard measurement. This falls under the definition of a diagnostic device as it helps identify a potential medical condition (irregular heartbeat).
No
The device description clearly states it is a "Wrist Electronic Blood Pressure Monitor" that uses an inflatable cuff and the oscillometric method, 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures blood pressure and heart rate non-invasively from the wrist using the oscillometric method. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and heart rate) directly from the patient's body.
Therefore, this blood pressure monitor falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
Product codes
DXN
Device Description
The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied).
There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 2 minute the device will shut down automatically.
The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult population, not applied to the other populations such as neonatal baby.
Intended User / Care Setting
At household
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
Clinical trials for the Wrist Electronic Blood Pressure Monitor were performed according to the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type. Relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 130 subjects selected to participate in the trial. Auscultation was applied as the gold standard with a qualified calibrated mercurial sphygmomanometer used as a control group for comparison with the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Test Conclusion:
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Wrist Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 130 subjects been selected to participate in the trial, and Auscultation applied as gold standard with the qualified calibrated mercurial was was was and sphygmomanometer used as control group for comparison with the subject device. The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the +/-5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-3 mmHg for BP, +/-5% of reading value for Pulse Accuracy.
The clinical trial results showed that the accuracy of the proposed device meets the requirements of ISO 81060-2:2018 within the +/-5mmHg.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
September 18, 2023
Shenzhen Finicare Co., Ltd. % Boyle Wang, Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K231367
Trade/Device Name: Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 21, 2023 Received: August 25, 2023
Dear Boyle Wang:
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 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.
Stephen C. Browning -S
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) K231367
Device Name
Wrist Electronic Blood Pressure Monitor (Model:FC-BP200, FC-BP210,FC-BP211,FC-BP211,FC-BP221)
Indications for Use (Describe)
This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K231367
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Address: | 201, No.50, the 3rd Industrial Park, Houting Community, Shajing |
| Street, Bao'an District, Shenzhen 518104 China | |
| Tel: | 86-755-23013503 |
| Contact: | Chao Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lu Jiazui Rd., Pudong,Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Aug.23,2023
2.0 Device Information
| Trade name: | Wrist Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive Blood Pressure Measurement System |
| Classification name: | Noninvasive Blood Pressure Measurement System |
| Model(s): | FC-BP200, FC-BP201, FC-BP210, |
| FC-BP211, FC-BP220, FC-BP221 | |
| Production code: | DXN |
| Regulation number: | 21 CFR 870.1130 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
| Manufacturer: | Shenzhen Kingyield Technology Co., Ltd. |
|---|---|
| Trade/Device name: | Bluetooth Blood Pressure Monitor, BPW1 |
4
510(k) number: K182018
4.0 Indication for Use Statement
This blood pressure monitor (Model: FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
5.0 Device Description
The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables
5
the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied).
There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 2 minute the device will shut down automatically.
The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
6.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012(Cons. Text) [Incl. AMD2:2021] - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-
1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2020, 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 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
EN 300328:2019 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques.
301489-1:2019 ElectroMagnetic Compatibility (EMC)standard for radio EN equipment and services;Part 1:Common technical requirements.
EN 301489-17:2020 Electromagnetic compatibility and Radio spectrum Matters
(ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems.
EN 62479:2010 Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic
6
fields (10 MHZ to 300 GHZ )
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
7.0 Clinical Test Conclusion
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Wrist Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 130 subjects been selected to participate in the trial, and Auscultation applied as gold standard with the qualified calibrated mercurial was was was and sphygmomanometer used as control group for comparison with the subject device. The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
8.0 Technological Characteristic Comparison Table
7
| Item | Subject Device
K231367 | Predicate Device
K182018 | Remark |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Shenzhen Finicare Co., Ltd. | Shenzhen Kingyield
technology Co., Ltd | / |
| Product Name | Wrist Electronic Blood Pressure
Monitor
FC-BP200, FC-BP201, FC-
BP210,FC-BP211, FC-BP220,
FC-BP221 | Bluetooth blood pressure
monitor, BPW1 | / |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Intended
Use/Indication
for Use | This blood pressure monitor
(Model: FC-BP200, FC-BP201,
FC-BP210, FC-BP211, FC-
BP220, FC-BP221) is intended to
be used to measure blood
pressure (systolic and diastolic)
and heart rate from the wrist by
using the oscillometric method.
The device detects the
appearance of irregular
heartbeats during measurement
and gives a symbol with reading.
The device is intended for using
in only adult population, not
applied to the other populations
such as neonatal baby. It can't be
used while the wrist (arm) has
bleeding or wound to avoid the
blood flowing from the wound in
pressurizing. The wrist
circumference is limited to 13.5cm
- 21.5cm. | This blood pressure monitor is
intended to be used to
measure blood pressure
(systolic and diastolic) and
heart rate from the wrist by
using the oscillometric method.
The device detects the
appearance of irregular
heartbeats during
measurement and gives a
symbol with reading. The
device is intended for using in
only adult population, not
applied to the other
populations such as neonatal
baby. It can't be used while the
wrist (arm) has bleeding or
wound to avoid the blood
flowing from the wound in
pressurizing. The wrist
circumference is limited to
13.5cm - 21.5cm | Same |
| Application Site | Wrist | Wrist | Same |
| Wrist
Circumference | 13.5cm - 21.5cm | 13.5cm - 21.5cm | Same |
| Patients
Contacting
Materials | Patient contact materials of the
cuff: Brushed Fabric
According to ISO-10993 | Zinc alloy for the case of the
device and ABS for Button.
Biocompatible materials are
used for the applied parts
(Bladder + wristband)
According to ISO-10993 | Different |
| Patient
Population | Adult | Adult | Same |
| Measurements
Item | SYS,DYS,Pulse | SYS,DYS,Pulse | Same |
| Display
| LCD Digital Display | LCD | Same |
| Item | Subject Device | Predicate Device
K182018 | Remark |
| Max Cuff
pressure | 300 mmHg | 300mmHg | Same |
| BP Range | 0-299 mmHg | 0 ~ 299 mmHg | Same |
| BP Accuracy | ±3 mmHg | ±3 mmHg | Same |
| PR Range | 40-180 beats/min | 40 ~ 180 beats/min | Same |
| Pulse Accuracy | ±5% of reading
value | ±5% of reading
value | Same |
| Irregular
heartbeat
detection | More than ±25% to the
mean interval of pulse
intervals. | More than ±25% to the
mean interval of pulse
intervals. | Same |
| Inflation
Method | Automatic inflation by pump | By air pump | Same |
| Deflation
Method | Automatic rapid deflation | Not apply | Different |
| Memory Size | 2x120 set of data | 30 set | Different |
| Operation
Condition | 1040°C85%RH
Humidity: 15
Atmospheric pressure: 70 -
106kPa | 1040℃,90%RH
Humidity:15
Atmospheric: 106kPa80kPa | Different |60 °C
| Storage
Condition | -20
Humidity: 10 to 95% RH | -20°C~ 55°C,
0~95%RH (noncondensing ) | Different |
| Power Supply | 2 AAA alkaline batteries, DC3V | Li-ion Rechargeable battery
with 250 charging cycles | Different |
| Performance
Standard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | Same |
Table1-General Comparison
Analysis:
8
The material of the wrist cuff of the subject device is different with that of the predicate device. Biocompatibility testing was carried out and the test results shown the materials of both devices are complied with the requirements of ISO 10993-1.
Table 2 Performance Comparison
Analysis:
The subject and predicate device have same general intended use, similar design features and performance specifications.
The differences in Memory Size do not raise different questions of safety or effectiveness since the device complied with the requirement of IEC 80601-2-30. The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. So we think the subject device is substantially equivalent to the predicate device.
Table 3 Safety Comparison
| Item | Proposed Device | Predicate Device
K182018 | Remark |
| ------ | ----------------- | ----------------------------- | -------- |
|---|
9
| Electrical Safety | Comply with ANSI AAMI
ES60601-1 | Comply with IEC 60601-1 | Same |
|-------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------|
| Home Use | Comply with IEC 60601-1-
11 | Comply with IEC 60601-1-11 | Same |
| EMC | Comply with IEC 60601-1-
2 | Comply with IEC 60601-1-2 | Same |
| FCC conformity | FCC 47 part 15 subject B
FCC 47 CFR Part 15,
Subpart C | FCC 47 CFR part 15,Subject B
FCC 47 CFR Part 15, Subpart C
FCC 47 CFR Part 1.1307
FCC 47 CFR Part 2.1093 | Same |
| ERM conformity | EN 301489-1:2017;
EN301489-17:2017 | EN 301489-1:2017;
EN 301489-17:2017 | Same |
| RF conformity | EN300328:2016 | EN300328:2016 | Same |
| Health | EN62479:2010 | EN62479:2010 | Same |
| Biocompatibility | Comply with ISO 10993-1,
FDA Guidance | Comply with ISO 10993-1, FDA
Guidance | Same |
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.