(109 days)
The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
AOJ-35 series wrist blood pressure monitor is designed as a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg. The device also has low voltage indication, which will be triggered when the battery is low. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 80601-2-30 & ISO 81060-2:2013) | Reported Device Performance (as per Clinical Data) |
|---|---|
| Blood Pressure Accuracy: Mean value of difference between device and reference standard should be less than 5.0 mmHg. | Mean value is less than 5.0 mmHg |
| Blood Pressure Accuracy: Standard deviation of difference between device and reference standard should be less than 8.0 mmHg. | Standard deviation is less than 8.0 mmHg |
| Cuff Size Distribution Requirement (ISO 81060-2:2013 clause 5.1.4): | |
| - Upper half of the cuff: At least 40% | 54% (Complied) |
| - Lower half of the cuff: At least 40% | 46% (Complied) |
| - Upper quarter of the cuff: At least 20% | 29% (Complied) |
| - Lower quarter of the cuff: At least 20% | 24% (Complied) |
| - Upper octal of the cuff: At least 10% | 11% (Complied) |
| - Lower octal of the cuff: At least 10% | 10% (Complied) |
| Blood Pressure Distribution Requirement (ISO 81060-2:2013 clause 5.1.5): | |
| - Systolic Blood Pressure ≤100 mmHg: At least 5% | 12% (Complied) |
| - Systolic Blood Pressure ≥160 mmHg: At least 5% | 13% (Complied) |
| - Systolic Blood Pressure ≥140 mmHg: At least 20% | 33% (Complied) |
| - Diastolic Blood Pressure ≥100 mmHg: At least 5% | 16% (Complied) |
| - Diastolic Blood Pressure ≤60 mmHg: At least 5% | 10% (Complied) |
| - Diastolic Blood Pressure ≥85 mmHg: At least 20% | 38% (Complied) |
| Non-Invasive Sphygmomanometer Performance Effectiveness | Complies with ISO 80601-2-30 |
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (Cytotoxicity, Skin Sensitization, Skin Irritation) |
| Software Verification and Validation | Passed according to FDA Guidance for "major" level of concern |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 subjects (49 female, 51 male).
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a prospective clinical study, as it was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document mentions that the clinical testing was conducted "per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard typically outlines the requirements for validation of automated non-invasive sphygmomanometers against a reference standard. While the document doesn't explicitly state the number of experts, ISO 81060-2 typically requires measurements by trained observers using a mercury-column or auscultatory device as the reference ground truth. The qualifications of these observers would be that they are trained to accurately perform manual blood pressure measurements according to the standard. No specific details about the number or precise qualifications (e.g., "radiologist with 10 years of experience") are provided in this summary, but the reference to the ISO standard implies adherence to its requirements for ground truth establishment.
4. Adjudication Method for the Test Set:
The document does not explicitly mention an adjudication method like 2+1 or 3+1. For blood pressure validation, ISO 81060-2 typically involves simultaneous or closely timed measurements by multiple trained observers (often two) and the device under test. The differences between the device readings and the average or adjudicated readings of the observers (or a specific protocol for handling discrepancies) form the basis of the accuracy assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study described focuses on the standalone accuracy of the blood pressure monitor against a reference standard, not its impact on human reader performance or diagnostic accuracy.
6. Standalone Performance Study:
Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The clinical data section explicitly details the performance of the "monitor" (the device) in measuring blood pressure and pulse rate against a reference standard. The "Bench Testing" section also describes tests conducted on the device's technical performance.
7. Type of Ground Truth Used:
The ground truth used for the clinical study was established according to ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. This standard mandates a clinical validation process where the automated device's measurements are compared to measurements taken by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This constitutes an expert-based reference standard rather than pathology or outcomes data.
8. Sample Size for the Training Set:
The document does not provide information on the sample size for the training set. This is a premarket notification for a medical device, and the focus of the provided summary is on the clinical validation (testing) and non-clinical data, not on the development or training of an AI algorithm (though the device itself likely contains algorithms, their training data is not detailed here).
9. How the Ground Truth for the Training Set was Established:
As no training set information is provided, how its ground truth was established is not detailed in this document.
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February 18, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Queena Chen Regulatory Director Room 301&4F, Blk A, Building A, Jingfa IM Park, Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China
Re: K213503
Trade/Device Name: Wrist Blood Pressure Monitor, models AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 20, 2021 Received: December 22, 2021
Dear Queena Chen:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K213503
Device Name
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D and AOJ-35E
Indications for Use (Describe)
The Wrist Blood Pressure Monitor is intended to measure and diastolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Shenzhen AOJ Medical Technology Co., Ltd.Room 301&4F, Block A, Building A,Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, XixiangStreet, Bao'an District, 518126, Shenzhen, ChinaTEL: 86 755-27786026 |
|---|---|
| Contact Person: | Queena Chen |
| Prepare date: | December 18, 2021 |
| 2. Device name andclassification: | Device Name: Wrist Blood Pressure MonitorModels: AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D and AOJ-35ERegulation No.: 21 CFR 870.1130Review Panel: CardiovascularClassification Name: Cardiovascular Diagnostic DevicesProduct code: DXNRegulatory Class: Class II |
| 3. Reason forSubmission: | New Application. No prior submission for this device before. |
| 3. Class III devicestatement | Not applicable, the subject device is a Class II device. |
| 4. Predicate Devices: | Primary predicate: Dongguan E-TEST Technology Co., Ltd., BW-602 AutomaticWrist Electronic Blood Pressure Monitor cleared under K193628.Reference predicate: Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30BElectronic Blood Pressure Monitor cleared under K191180. |
| 5. Device Description: | The predicates has not been subject to any recall before.AOJ-35 series wrist blood pressure monitor is designed as a battery drivenautomatic on-invasive blood pressure monitor. It can automatically complete theinflation, deflation and measurement, which can measure systolic and diastolicblood pressure as well as the pulse rate of adult person at wrist within its claimedrange and accuracy via the oscillometric technique. The result will be displayed inthe international unit mmHg.The device also has low voltage indication, which will be triggered when the batteryis low.All the models included in this submission follow the same software, samemeasurement principle and same specifications. The main differences are color ofthe face shell and keys, which will not affect the safety and effectiveness of thedevice. |
| 6. Indications forUse: | The Wrist Blood Pressure Monitor is intended to measure the systolic pressure anddiastolic pressure, as well as the pulse rate of adult person via non-invasiveoscillometric technique by an inflatable cuff wrapped around the wrist at medicalfacilities or at home. |
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7. Predicate Device Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
| ITEM | Proposed Device | Predicate Device | ComparisonResult |
|---|---|---|---|
| AOJ-35A series | BW-602/K193628 | ||
| Manufacturer | Shenzhen AOJ MedicalTechnology Co., Ltd. | DONGGUAN E-TESTTECHNOLOGY CO., LTD | --- |
| IntendedUse/Indications forUse | The Wrist Blood PressureMonitor is intended to measurethe systolic pressure anddiastolic pressure, as well as thepulse rate of adult person vianon-invasive oscillometrictechnique by an inflatable cuffwrapped around the wrist atmedical facilities or at home. | Automatic Wrist Blood PressureMonitor is for use by medicalprofessionals or at home and is anon invasive blood pressuremeasurement system intended tomeasure the diastolic andsystolic blood pressures andpulse rate of an adult individualby using a non-invasivetechnique in which an inflatablecuff is wrapped around thewrist. The cuff circumference islimited to 13.5 cm~19.5 cm. | Different |
| Operational Specifications | |||
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Patient population | Adult | Adult | Same |
| Measurement site | Wrist | Wrist | Same |
| Blood pressureMeasurement range | 0 - 295 mmHg | 0 - 294 mmHg | Different |
| Blood pressureaccuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Pulse ratemeasurement range | 40-199 bpm | 40-199 bpm | Same |
| Pulse rate accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 13.5~19.5cm | 13.5~19.5cm | Same |
| Display | Blood Pressure (Systolic andDiastolic), Pulse rate, Time,Date, BP Indicating Bar, LowBattery Icon, Heart Icon,Memory Record Number | Blood Pressure (Systolic andDiastolic), Pulse rate, Date,Time, BP Indicating Bar, LowBattery Icon, Heart Icon,Memory Record Number | Same |
| Screen | LCD | LCD | Same |
| Auto shutdown | YES | YES | Same |
| Operatingenvironment | Temperature: 5°C~40°CHumidity: 15%-90% RH,Atmospheric pressure:70 kPa - 106 kPa | Temperature: 5°C~40°CHumidity: 15%-90% RH,Atmospheric pressure:86 kPa - 106 kPa | Different |
| Storage environment | Ambient Temperature:20°C to 55°C | Ambient Temperature:20°C to 65°C | Same |
| Relative Humidity: 10-93% RH,Atmospheric pressure:70 kPa - 106 kPa | Relative Humidity: 15-95% RH,Atmospheric pressure:86 kPa - 106 kPa | ||
| Battery type | 3Vdc (2 *AAA batteries) | 3Vdc (2 *AAA batteries) | Same |
| Weight | Approx. 126 g without battery | Approx. 150 g without battery | Different |
| Dimensions | AOJ-35A/AOJ-35B/AOJ-35D:90 mm x 66 mm x 28.5 mmAOJ-35C/AOJ-35E:79.6 mm x 70 mm x 26.8 mm | 72.69 mm x 64 mm x 28 mm | |
| Patient Contacting | Surface-contacting,Less than 24 h | Surface-contacting,Less than 24 h | Same |
| Biocompatibilityevaluation | Cytotoxicity, skin sensitizationand irritation | Cytotoxicity, skin sensitizationand irritation | Same |
| Electrical safety | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Same |
Table 1 Comparison between predicate BW-602 and the subject device
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Table 2 Comparison between predicate AOJ-30B and the subject device
| ITEM | Proposed DeviceAOJ-35A series | Predicate DeviceAOJ-30B/K191180 | ComparisonResult |
|---|---|---|---|
| Manufacturer | Shenzhen AOJ Medical Technology Co., Ltd. | Shenzhen AOJ Medical Technology Co., Ltd. | --- |
| IntendedUse/Indications forUse | The Wrist Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique by an inflatable cuff wrapped around the wrist at medical facilities or at home. | The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home. | Same |
| Operational Specifications | |||
| Principle | Oscillometric | Oscillometric | Same |
| Measurement Item | SYS, DYS, Pulse Rate | SYS, DYS, Pulse Rate | Same |
| Patient population | Adult | Adult | Same |
| Measurement site | Wrist | Arm | Same |
| Blood pressuremeasurement range | 0 - 295 mmHg | 0 - 295 mmHg | Same |
| Accuracy | ± 3 mmHg | ± 3 mmHg | Same |
| Heart ratemeasurement range | 40-199 bpm | 40-199 bpm | Same |
| Accuracy | ± 5% of reading | ± 5% of reading | Same |
| Cuff size | 13.5~19.5cm | 22~36cm | Different |
| Display | Blood Pressure (Systolic and Diastolic), Pulse rate, Date, Time, WHO BP Classification Indicating Bar, Low Battery | Blood Pressure (Systolic and Diastolic), Pulse rate, Date, Time, WHO BP Classification Indicating Bar, Low Battery | Same |
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| Icon, Heart Icon, Memory Record Number | Icon, Heart Icon, Memory Record Number | ||
|---|---|---|---|
| Auto shutdown | YES | YES | Same |
| Operating environment | Temperature: 5°C~ 40°CHumidity: 15%-90% RH,Atmospheric pressure:70 kPa - 106 kPa | Temperature: 5°C~ 40°CHumidity: 15%-90% RH,Atmospheric pressure:70 kPa - 106 kPa | Same |
| Storage environment | Ambient Temperature:-20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa - 106 kPa | Ambient Temperature:-20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa - 106 kPa | |
| Battery type | 3Vdc (2 *AAA batteries) | 6Vdc (4 *AA batteries) | Different |
| Weight | Approx. 126 g without battery | Approx. 483.8 g without battery | Different |
| Dimensions | AOJ-35A/AOJ-35B/AOJ-35D:90 mm x 66 mm x 28.5 mmAOJ-35C/AOJ-35E:79.6 mm x 70 mm x 26.8 mm | 138 mm x 120 mm x 59 mm | |
| Patient Contacting | Surface-contacting,Less than 24 h | Surface-contacting,Less than 24 h | Same |
| Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization and irritation | Same |
| Electrical safety | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Same |
As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The differences between the subject and predicate devices will not raise different questions of safety or effectiveness. Moreover, as demonstrated in the bench testing, the different technological characteristics do not affect the safety and effectiveness of the subject device.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:
- □ Cytotoxicity
- □ Skin Sensitization
- □ Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
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Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Reguirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the device, consisting of all the accessories in the system. The system complies with the ISO 80601-2-30 Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injurv or death to the patient or operator.
Clinical data:
The clinical testing has been conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type on the monitor. There are 100 subjects involved in the stufy, of which 49 femal and 51 male. All the subjects are aged greater than 12 years old. And the wrist size distribution meets the requirements described in clause 5.1.4 of the standard as shown in Table 3. Also the blood pressure distribution matches the requirements defined in clause 5.1.5 of the standard shown in the following Table 4. And themean value is less than 5.0 mmHg, and standard deviation is also less than 8.0 mmHg after final analyzed.
| Size distribution | Pecentage | Compared to the requirements in standards |
|---|---|---|
| Upper half of the cuff | 54% | At least 40%, complied |
| Lower half of the cuff | 46% | At least 40%, complied |
| Upper quarter of the cuff | 29% | At least 20%, complied |
| Lower quarter of the cuff | 24% | At least 20%, complied |
| Upper octal of the cuff | 11% | At least 10%, complied |
| Lower octal of the cuff | 10% | At least 10%, complied |
Table 3 Size distribution of the subjects
Table 4 Blood pressure distribution of the subjects
| Range | Percentage | Compared to the requirements in standards | |
|---|---|---|---|
| Systolic bloodpressure | ≤100 mmHg | 12% | At least 5%, complied |
| ≥160 mmHg | 13% | At least 5%, complied | |
| ≥140 mmHg | 33% | At least 20%, complied | |
| Diastolic bloodpressure | ≥100 mmHg | 16% | At least 5%, complied |
| ≤60 mmHg | 10% | At least 5%, complied | |
| ≥85mmHg | 38% | At least 20%, complied |
Summarv
Based on the non-clinical performance data as documented in the device development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
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9. Conclusion:
Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-35 series Wrist Blood Pressure Monitor is substantially equivalent to the predicate devices.
§ 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).