(111 days)
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AA alkaline batteries.
The devices also compares 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 pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: Automatic Arm Bluetooth Blood Pressure Monitor (Models DB62, DB63, DB85)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ISO81060-2 Standard. The reported device performance refers to the results of the clinical study.
| Acceptance Criterion (ISO81060-2) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Criterion 1: Mean difference of ≤ 5 mmHg, with a standard deviation of differences of ≤ 8 mmHg | |
| - Mean Difference (Systolic) | 2.5 mmHg (meets criterion) |
| - Mean Difference (Diastolic) | 1.8 mmHg (meets criterion) |
| - Standard Deviation (Systolic) | 3.45 mmHg (meets criterion) |
| - Standard Deviation (Diastolic) | 3.30 mmHg (meets criterion) |
| Criterion 2: Standard Sm of the averaged paired determinations per subject (deviation, sphygmomanometer-under-test and reference sphygmomanometer) meets the criteria in Table 1 (provided in document). | |
| - Standard Sm (Systolic) | 2.56 mmHg (Implicitly meets criterion, as the clinical study concludes the device is "safe and effective" based on these results) |
| - Standard Sm (Diastolic) | 2.10 mmHg (Implicitly meets criterion, as the clinical study concludes the device is "safe and effective" based on these results) |
Note on Criterion 2: The document provides a table for Maximum permissible standard deviation, Sm, as a function of mean error, xn. The reported Std for Criterion 2 (2.56 mmHg for systolic and 2.10 mmHg for diastolic) would need to be compared against the values in this table based on the reported mean errors (2.5 mmHg for systolic and 1.8 mmHg for diastolic) to explicitly confirm conformance. However, the study directly states, "Through clinical research, we can convinced that the clinical device is safe and effective," implying these values met the standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 85 subjects.
- Data Provenance: The clinical study was conducted in a hospital. This suggests prospective data collection in a clinical setting, likely in the country of origin of the manufacturer (China), though not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Two doctors.
- Qualifications of Experts: The document states "Simultaneous and blinded blood pressure determinations were performed by two doctors." Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond "doctors."
4. Adjudication Method for the Test Set
- Adjudication Method: Implicitly, a simultaneous and blinded comparison against a standard mercury sphygmomanometer (reference standard) with two doctors performing the determinations. This suggests that the readings from the two doctors on the reference standard formed a consensus or averaged ground truth against which the device was compared. The document does not specify a formal adjudication process like "2+1" or "3+1" for resolving discrepancies between the two doctors, but rather implies their measurements constituted the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No, a MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.
6. Standalone Performance Study
- Was a standalone study done? Yes, the clinical study performed was a standalone study of the algorithm's performance. The device itself (Automatic Arm Bluetooth Blood Pressure Monitor) is the "algorithm only" in this context, as it automatically measures and displays blood pressure readings without a human-in-the-loop directly interpreting raw signals. Its performance was measured against the reference standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established using a standard mercury sphygmomanometer as a reference standard, with simultaneous and blinded blood pressure determinations performed by two doctors. This is a form of expert consensus/reference measurement, widely accepted for blood pressure monitor validation.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not provide information regarding a specific training set or its sample size. This is common for devices that use established physiological measurement principles (like the oscillometric method for blood pressure) rather than complex machine learning models that require explicit training on large datasets for regulatory submission. The "oscillometric method" itself is a well-known technique.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: As no specific training set is mentioned, the method for establishing its ground truth is not applicable/not provided in this document. The device operates based on the "oscillometric method," which is a pre-established principle rather than a continuously learning algorithm requiring a dedicated, labeled training set like many AI/ML devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
Truly Instrument Limited % Max Wong, Corporate Secretary Truly (U.S.A) Inc 2620 Concord Avenue, Suite 106 Alhambra, California 91803
Re: K161846 Trade/Device Name: Automatic Arm Bluetooth Blood Pressure Monitor, with models DB62, DB63 and DB85 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 27, 2016 Received: October 4, 2016
Dear Max Wong:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K161846
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161846
Device Name
Automatic Arm Bluetooth Blood Pressure Monitor
Indications for Use (Describe)
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-67
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Image /page/3/Picture/0 description: The image shows the alphanumeric string "K161846". The string is written in a simple, sans-serif font. The characters are black against a white background, providing a clear contrast.
Image /page/3/Picture/1 description: The image contains the word "TRULY" in large, red, bold letters. There is a registered trademark symbol to the right of the word. A black line is located underneath the word.
510(k) Summary
V1.1
Date of Summary Preparation: Jan.16.2015
1. Submitter's Identifications
| Submitter's Name: | Truly Instrument Limited |
|---|---|
| Address: | Site 2, Truly Industrial Area, Shanwei City,Guangdong Province, China |
| Contact Person: | Manager Yang Jian-Hao |
| Telephone: | 86-0660-3380070 |
| Fax: | 86-0660-3380377 |
2. Name of the Device
| Device Classification Name: | System, Measurement, Blood-Pressure, Non-invasive | |
|---|---|---|
| Trade Nam: | Automatic Arm Bluetooth Blood Pressure Monitor | |
| Models: | DB62, DB63, DB85 | |
| Classification Panel: | cardio-vascular | |
| Common/Usual Name: | Automatic Arm Blood Pressure Monitor | |
| Product Code: | DXN | |
| Device Classification: | Class II | |
| Contraindications : | N/A |
3. The Predicate Devices
- 3-1. YA HORNG Electronic Co., Ltd
Upper Arm Blood Pressure Monitor. Model BP-700NW and Bluetooth Transmission BP-700W.
K Number : K121025
- 3-2. TRULY Instrument Limited. Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M. K Number :K091434
4. Device Description
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a
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Image /page/4/Picture/1 description: The image contains the word "TRULY" in red, with a registered trademark symbol next to it. The word is in a bold, sans-serif font and is slightly slanted to the right. A black line is present underneath the word.
single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AA alkaline batteries.
The devices also compares 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 pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol. .
5. Intended use of device
Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .
6. Technological Characteristics of our new DEVICE COMPARED TO THE
PREDICATE DEVICE:
6-1:The technological characteristics of Truly Automatic Arm Bluetooth Blood Pressure Monitor, models DB62, DB63, DB85 are substantially equivalent to Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M.( K091434). There is the same Owner, TRULY instrument Limited. Which FDA owner number is 9055362. our new devices DB62. DB63. DB85 are the upgraded version to include the Bluetooth 4.0 Wireless function. In addition, there are the same dseign specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.
| Parameter | Predicate DevicesDB62M(K091434) | DB62 | DB63 | DB85 | Result |
|---|---|---|---|---|---|
| Indicationsfor use | Measuring systolic anddiastolic blood pressure andpulse rate of adult individualby using a non-incasivetechnique in which aninflatable cuff is wrappedaround the upper arm,,The devices features include | Truly Automatic Arm Bluetooth BloodPressure Monitor DB series, ModelsDB62, DB63, DB85 are a series devicesintended to measure the systolic anddiastolic blood pressure and pulse rate ofan adult individual by using anon-invasive technique in which aninflatable cuff is wrapped around the | Same |
Table-6-1: The comparison table
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| RULY® | ||
|---|---|---|
| -- | -- | ------- |
| Parameter | Predicate DevicesDB62M(K091434) | DB62 | DB63 | DB85 | Result |
|---|---|---|---|---|---|
| irregular pulse nrhythmdetection duringmeasurement, and display awarning signal with thereading once the irregularheartbeat is detected. .Over-The-Counter Use | upper arm.The devices' features include irregularpulse rhythm detection duringmeasurement, and will display a alertsignal with the reading when irregularheartbeat is detected.The devices' feature include Bluetoothfunction to transmit data to an externalBluetooth device with wirelesscommunication ..Over-The-Counter Use | ||||
| TargetPopulation | Adult | Adult | Same | ||
| Anatomicalsites | Upper Arm | Upper Arm | Same | ||
| Where used(hospital,home,ambulance.etc) | Home | Home | Same | ||
| Energy usedand / ordelivered | 4x 1.5V AA Battery | 4x 1.5V AA Battery | Same | ||
| Humanfactors | Blood pressure | Blood pressure | Same | ||
| MeasurementalgorithmMethod | Oscillometric method | Same | |||
| Cuff | No change ,all same According to ISO-10993 | Same | |||
| Irregularheartbeatdetection | More than ±25% to the mean interval of pulse intervals. | ||||
| MeasurementPressureRange | 20 ~ 280 mmHg | No change ,all same | Same | ||
| MeasurementPulse Range | 40 ~ 195 beats/min | No change ,all same | |||
| Mesauringresolution | 1 mmHg | No change ,all same | |||
| AccuracyPressure | ±3mmHg | No change ,all same | |||
| AccuracyPulse | ±5% | No change ,all same |
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| Truly Instrument Limited | |||||
|---|---|---|---|---|---|
| Parameter | Predicate DevicesDB62M(K091434) | DB62 | DB63 | DB85 | Result |
| PCB | 1. The major PCB is all all same.2. There is BLE module to direct connect to major PCB via the port RX and TX on the new Bluetooth models DB62,DB63,DB85. | ||||
| Software | Upgrade the software to include the data transmit with Uart protocol on the new Bluetooth models DB62, DB63, DB85. | ||||
| Compatibilitywith theenvironmentand otherdevices | Operation Environment:10°C~ 40°C, 15% | Same | |||
| Electricalsafety | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | Same | ||
| Mechanicalsafety | Same | Same | Same |
6-2: Besides, the devices DB62, DB63, DB85 and the other predicate device YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model Bluetooth Transmission BP-700W( K121025) are also with the wireless communication function connect to an external Bluetooth enable device for data receiving and storage.
Table-6-1: The comparison table
| Parameter | Predicate DevicesBP-700W(K121025) | DB62 | DB63 | DB85 | Result |
|---|---|---|---|---|---|
| Indicationsfor use | The YA HORNG UpperArm Blood PressureMonitor, mondel BP-700NWand Bluetooth TransmissionBP-700W are noninvasiveblood pressure measurementsystems intended to measurethe systolic and diastolicblood pressures and pulserate of an adult individual,over age 18, at home byusing a non-invasive using anon-invasive technique inwhich an inflatable cuff iswrapped around the upperarm, The cuff circumferenceis limited to be 9.0''~13.0''for Arm type.Optional models: BP-700Wwith Bluetooth module forthe wireless communication | Truly Automatic Arm Blood PressureMonitor DB series, Models DB62, DB63,DB85 are a series devices intended tomeasure the systolic and diastolic bloodpressure and pulse rate of an adultindividual by using a non-invasivetechnique in which an inflatable cuff iswrapped around the upper arm. | The devices' features include irregularpulse rhythm detection duringmeasurement, and will display a alertsignal with the reading when irregularheartbeat is detected.The devices' feature include Bluetoothfunction to transmit data to an externalBluetooth device with wirelesscommunication .Over-The-Counter Use | Same | |
| Parameter | Predicate DevicesBP-700W(K121025)function connectes to the PCfor record archiving andprinting purposes.Over-The-Counter Use | DB62 | DB63 | DB85 | Result |
| TargetPopulation | Adult | Adult | Same | ||
| Anatomicalsites | Upper Arm | Upper Arm | Same | ||
| Where used(hospital,home,ambulance.etc) | Home | Home | Same | ||
| Energy usedand / ordelivered | 4x 1.5V AA Battery | 4x 1.5V AA Battery | Same | ||
| Humanfactors | Blood pressure | Blood pressure | Same | ||
| MeasurementalgorithmMethod | Oscillometric method | No change ,all same | Same | ||
| Cuff | Size: 9" | Size: 220mm~340mm | Slightlydifferent | ||
| Irregularheartbeatdetection | More than ±25% to the mean interval of pulse intervals. | ||||
| MeasurementPressureRange | 20 ~ 280 mmHg | No change ,all same | Same | ||
| MeasurementPulse Range | 40 ~ 200 beats/min | 40 ~ 195 beats/min | Slightlydifferent | ||
| Mesauringresolution | 1 mmHg | No change ,all same | Same | ||
| AccuracyPressure | ±3mmHg | No change ,all same | Same | ||
| AccuracyPulse | ±5% | No change ,all same | Same | ||
| Electricalsafety | According to IEC60601-1-2According to IEC60601-1 | According to IEC60601-1-2According to IEC60601-1 | Same | ||
| Parameter | Predicate DevicesBP-700W(K121025) | DB62 | DB63 | DB85 | Result |
| Mechanicalsafety | Same | Same | Same |
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Image /page/8/Picture/1 description: The image contains the word "TRULY" in red, bold letters. To the right of the word is a small red circle with the letter R inside, indicating a registered trademark. The word is displayed in a simple, sans-serif font, and the overall design is clean and straightforward.
7. Summary of Clinical study
-
1). Subjects:
Eighty-five subjects in the hospital were participated in clinical study. -
2). Method:
A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors. -
3). Criteria:
The ISO81060-2 Standard recommended : -
A. a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg between test device and reference method.
B.
For the systolic and diastolic blood pressures for each of the m subjects, the standard Sm, of the averaged paired determinations per subject of the deviation, sphygmomanometer-under-test and of the reference sphygmomanometer shall meet the criteria listed in Tab 1 when calculated according to Equation(3).
| $\overline{x}_n$ | Maximum permissible standard deviation, $s_m$ , as function of mean error, $\overline{x}_n$mmHg | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0,0 | 0,1 | 0,2 | 0,3 | 0,4 | 0,5 | 0,6 | 0,7 | 0,8 | 0,9 | |
| ± 0, | 6,95 | 6,95 | 6,95 | 6,95 | 6,93 | 6,92 | 6,91 | 6,90 | 6,89 | 6,88 |
| ± 1, | 6,87 | 6,86 | 6,84 | 6,82 | 6,80 | 6,78 | 6,76 | 6,73 | 6,71 | 6,68 |
| ± 2, | 6,65 | 6,62 | 6,58 | 6,55 | 6,51 | 6,47 | 6,43 | 6,39 | 6,34 | 6,30 |
| ± 3, | 6,25 | 6,20 | 6,14 | 6,09 | 6,03 | 5,97 | 5,89 | 5,83 | 5,77 | 5,70 |
| ± 4, | 5,64 | 5,56 | 5,49 | 5,41 | 5,33 | 5,25 | 5,16 | 5,08 | 5,01 | 4,90 |
| ± 5, | 4,79 | - | - | - | - | - | - | - | - | - |
| EXAMPLE For mean error of ± 4,2, the maximum permissible standard deviation is 5,49. |
Table 1 - Averaged subject data acceptance (criterion 2)
4). Result
Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.
| Criterion 1 | Criterion 2 | ||||
|---|---|---|---|---|---|
| Diff(Systolic) | Diff (diastolic) | Diff(Systolic) | Diff (diastolic) | ||
| Mean | 2.5mmHg | 1.8mmHg | Mean | 2.5mmHg | 1.8mmHg |
| Std. | 3.45mmHg | 3.30mmHg | Std | 2.56mmHg | 2.10mmHg |
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Image /page/9/Picture/1 description: The image shows the word "TRULY" in large, bold, red letters. To the right of the word, there is a small, circular "R" symbol, indicating that the word is a registered trademark. The font of the word is sans-serif and the letters are closely spaced together.
Test Summary:
8-1. Electric Safety , EMC and FCC test reports.
| IEC/EN 60601-1:2007 | |
|---|---|
| General safety | IEC/EN60601-1-11 |
| EN60950-1:2011 | |
| EMC conformity | IEC/EN 60601-1-2:2010 |
| FCC conformity | FCC 47 part 15 subject B class B |
| ERM conformity | EN30148-1:2008, |
| EN30148-17:2009 | |
| RF conformity | EN300328:2006 |
| Health | EN62479:2010 |
8-2. Performance & Clinical Test ANSI/AAMI SP10:2002 ANSI/AAMI ISO 81060-2:2009
9. Conclusions
The new subject series devices of Truly Automatic Arm Bluetooth Blood Pressure Monitor continue to follow principles design of the predicate device DB62M(K091434), only upgraded to include the Bluetooth module . for the wireless communication function connects to an external Bluetooth enable device for data receiving and storage purposes . and the addition function Bluetooth substantially is equivalent to the predicate produce YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model Bluetooth Transmission BP-700W(K121025) .
§ 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).