(173 days)
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI/ML terms, image processing, or data sets for training/testing.
No
The device measures blood pressure and pulse rate; it does not provide therapy or treatment.
No
The device measures physiological parameters (blood pressure and pulse rate) but does not provide a diagnosis or interpret these measurements to identify a disease state. It is a monitoring device.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure meter" and mentions an "inflatable cuff," indicating it includes hardware components beyond just software.
Based on the provided information, the AGE Automatic Upper Arm Blood Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids outside of the body.
- The AGE Automatic Upper Arm Blood Pressure Monitor is a non-invasive device. It measures blood pressure and pulse rate directly from the patient's upper arm using a cuff. This is a physical measurement taken on the body, not a test performed on a specimen from the body.
- The intended use and device description clearly state it measures blood pressure and pulse rate using a cuff wrapped around the upper arm. There is no mention of collecting or analyzing any biological specimens.
Therefore, the AGE Automatic Upper Arm Blood Pressure Monitor falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures 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 cuff circumference is six sizes.
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Product codes
DXN
Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm / arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Medical professionals or at home
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)
AGE Automatic Upper Arm Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005 + A1:2012
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. (Cardiovascular)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ±3 mmHg, Pulse: ±5%
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Ageless Health Industrial Co., Ltd % Cecelia Ceng Regulatory Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN
Re: K153552
Trade/Device Name: AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X (X can be A, B, C, D, E, F). Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 25, 2015 Received: December 11, 2015
Dear Cecelia Ceng:
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
1
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 the quality systems (QS) 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 yours. Shawn W. Forrest -S 2016.06.01 22:58:44 -04'00'
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153552
Device Name
AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-801X, BA-802X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X (X can be A, B, C, D, E, F).
Indications for Use (Describe)
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures 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 cuff circumference is six sizes.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☐ Registration Use (Part 21 CFR 601 Subpart D)☒ One-Time Central Use (21 CFR 601 Subpart G) | ☐ Registration Use (Part 21 CFR 601 Subpart D) | ☒ One-Time Central Use (21 CFR 601 Subpart G) |
| ☐ Registration Use (Part 21 CFR 601 Subpart D) | ☒ One-Time Central Use (21 CFR 601 Subpart G) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Chapter 6. 510(k) Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 870.1130.
Submitter Information 1.
Sponsor Name: Dongguan Ageless Health Industrial Co., Ltd Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongquan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: +86-769-81158038 Fax: +86-769-82289331 E-mail: victor@agelh.com
Application Correspondent:
Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: requlatory@glomed-info.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| Classification Name: | Noninvasive blood pressure measurement system |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |
4
| Sponsor: | Dongguan Ageless Health Industrial Co., Ltd |
|---|---|
| Common Name: | Noninvasive blood pressure measurement systems |
| Trade Name: | AGE Automatic Upper Arm Blood Pressure Monitor |
| 510(k) number: | K123882 |
| Review Panel: | Cardiovascular |
| Product Code: | DXN |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |
4. Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
5. Intended Use
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Test Summary 6.
AGE Automatic Upper Arm Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005 + � A1:2012
- � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014
- � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010
- � AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. (Cardiovascular)
5
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Product Name | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor | -- | ||
| Intended Use and Indications for Use | |||
| Intended Use | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor is intended for | |||
| use by medical professionals or at | |||
| home to monitor and display | |||
| diastolic, systolic blood pressure | |||
| and pulse rate on adult each time, | |||
| with the cuff around the left upper | |||
| arm according to the instruction in | |||
| the user's guide manual. | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor is intended for | |||
| use by medical professionals or at | |||
| home to monitor and display | |||
| diastolic, systolic blood pressure | |||
| and pulse rate on adult each time, | |||
| with the cuff around the left upper | |||
| arm according to the instruction in | |||
| the user's guide manual. | SE | ||
| Indications for | |||
| Use | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor is for use by | |||
| medical professionals or at home | |||
| and is a non-invasive blood | |||
| pressure measurement system | |||
| intended to measure the diastolic | |||
| and systolic blood pressures 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 cuff | |||
| circumference is six sizes. | AGE Automatic Upper Arm Blood | ||
| Pressure Monitor is for use by | |||
| medical professionals or at home | |||
| and is a non-invasive blood | |||
| pressure measurement system | |||
| intended to measure the diastolic | |||
| and systolic blood pressures 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 cuff | |||
| circumference is limited to 24~34 | |||
| cm. | SE | ||
| Note 1 | |||
| ELECTRICAL REQUIREMENT | |||
| Power Supply | DC 6V (4 X AA 1.5V alkline | ||
| batteries) | 6Vdc (4 "AA" batteries) | SE | |
| PERFORMANCE SPECIFICATION | |||
| Measuring | |||
| Method | Oscillometry | Oscillometry | SE |
| Measurement | |||
| range for | |||
| pressure | 0~280 mmHg | 0~280 mmHg | SE |
| Operating | |||
| Range for | |||
| Pressure (Cuff | |||
| Pressure) | 0~280 mmHg | 0~280 mmHg | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Cuff Display | |||
| Range | 0~280 mmHg | 0~280 mmHg | SE |
| Pressure | |||
| resolution | 1mmHg or 0.1kPa | 1mmHg or 0.1kPa | SE |
| Accuracy | Pressure: ±3 mmHg | ||
| Pulse: ±5% | Pressure: ±3mmHg | ||
| Pulse: ±5% | SE | ||
| Patient | |||
| Population | Adult | Adult | SE |
| Measurement | |||
| Site of Body | Upper Arm | Upper Arm | SE |
| Inflation and | |||
| Deflation | Automatic | Automatic | SE |
| Memory Size | 2 x 90 sets record (BA-822X is 90 | ||
| sets ) | 2 x 90 sets record | SE | |
| Note 2 | |||
| Software | |||
| Version | V01 | V1.1 | SE |
| Note 3 | |||
| Indicators | Blood Pressure (Systolic and | ||
| Diastolic), Pulse, Date, Time, WHO | |||
| BP Classification Indicating Bar, | |||
| Low Battery Icon, Heart Icon, | |||
| Memory Record Number | Blood Pressure (Systolic and | ||
| Diastolic), Pulse, Date, Time, WHO | |||
| BP Classification Indicating Bar, | |||
| Low Battery Icon, Heart Icon, | |||
| Memory Record Number | SE | ||
| Physical | |||
| Dimensions | |||
| Weight | Please refer to "Table 1 Physical Dimensions and weight for each model" | ||
| of "Chapter 6" | SE | ||
| Note 4 | |||
| Cuff | |||
| Circumference | size A: 17cm--22cm (SMALL | ||
| ADULT CUFF) | |||
| size B: 22cm--30cm (ADULT | |||
| CUFF-1) | |||
| size C: 24cm--34cm (ADULT | |||
| CUFF-2) | |||
| size D: 22cm--42cm (L-LARGE | |||
| ADULT CUFF) | |||
| size E: 30cm--42cm (LARGE | |||
| ADULT CUFF) | |||
| size F: 42cm--50cm (EXTRA | |||
| LARGE ADULT CUFF) | 24~34 cm | SE | |
| Note 1 | |||
| OPERATING & STORAGE CONDITIONS | |||
| Storage | |||
| Environment | Temperature: -20°C ~ +65°C | ||
| Humidity: 10~95%RH | |||
| Atmospheric Pressure:86 kPa~106 | |||
| kPa | Temperature: -20°C ~ +65°C | ||
| Humidity: 10~95%RH | |||
| Atmospheric Pressure:86 kPa~106 | |||
| kPa | SE | ||
| Working | |||
| Environment | Temperature: 5°C ~ 40°C | ||
| Humidity: 15~90%RH | |||
| Atmospheric Pressure:86 kPa~106 | Temperature: 5°C ~ 40°C | ||
| Humidity: 10~90%RH | |||
| Atmospheric Pressure:86 kPa~106 | |||
| kPa | SE | ||
| Note 2 | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| kPa | |||
| COMPLIANCE STANDARDS | |||
| Electrical, | |||
| Mechanical and | |||
| Thermal | |||
| Evaluation | IEC 60601-1 | ||
| IEC 60601-1-2 | IEC 60601-1 | ||
| IEC 60601-1-2 | SE | ||
| Biocompatibility | |||
| Evaluation | All the patient contracting materials | ||
| are evaluated by the | |||
| biocompatibility standard ISO | |||
| 10993 -5, -10. | All the patient contracting materials | ||
| are evaluated by the | |||
| biocompatibility standard ISO | |||
| 10993 -5, -10. | SE | ||
| Performance | ISO 81060-2 | AAMI SP10 | SE |
| Note 5 |
6
7
Note 1
Although there is difference for measurement cuff circumference of subject device and predicate device, both of them are complied with ISO 81060-2. This difference does not affect the safety and effectiveness.
Note 2
Although some specifications of operating & storage conditions, memory size are different for subject device and predicate device, they are both complied with IEC 60601-1. The differences do not affect the safety and effectiveness. The storage and operating pressure ranges of subject device and predicate device are same, and the storage and operating pressure ranges of predicate device was provided by the manufacturer.
Note 3
The software version of subject device is updated based on the predicate device, there is no different in PWB control circuit and software among models. The software is same as K123882.
Note 4
These differences of physical dimensions and weight have been verified and validated to demonstrate that it does not affect the safety and effectiveness of subject device.
Note 5
Although the standards of performance have updated and substituted from AAMI SP10 to ISO 81060-2, all of the requirements in these three standards are intended for blood pressure monitor. Therefore,
8
both of them met the requirements. The differences do not affect the safety and effectiveness.
9
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-801X | Image: Blood pressure monitor | 115mm (L) | |||
| 103mm (W) | |||||
| 67.5mm (H) | |||||
| 460g | BA-801 | Image: Blood pressure monitor | 115mm (L) | ||
| 103mm (W) | |||||
| 67.5mm (H) | |||||
| 460g | |||||
| BA-802X | Image: Blood pressure monitor | 115mm (L) | |||
| 103mm (W) | |||||
| 67.5mm (H) | |||||
| 460g | BA-802 | Image: Blood pressure monitor | 115mm (L) | ||
| 103mm (W) | |||||
| 67.5mm (H) | |||||
| 460g |
10
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-803X | Image: Blood pressure monitor | 119mm (L) | |||
| 100mm (W) | |||||
| 63.2mm (H) | |||||
| 456g | BA-803 | Image: Blood pressure monitor | 119mm (L) | ||
| 100mm (W) | |||||
| 63.2mm (H) | |||||
| 456g | |||||
| BA-805X | Image: Blood pressure monitor | 118.3mm (L) | |||
| 100mm (W) | |||||
| 62.9mm (H) | |||||
| 465g | BA-805 | Image: Blood pressure monitor | 118.3mm (L) | ||
| 100mm (W) | |||||
| 62.9mm (H) | |||||
| 465g |
11
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-806X | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L) | |||
| 112mm (W) | |||||
| 70mm (H) | |||||
| 472g | BA-806 | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L) | ||
| 112mm (W) | |||||
| 70mm (H) | |||||
| 472g | |||||
| BA-811X | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L) | |||
| 112mm (W) | |||||
| 67mm (H) | |||||
| 468g | BA-811 | Image: Blood pressure monitor with arm cuff, LCD screen, and buttons labeled Memory, Power, and Set | 144mm (L) | ||
| 112mm (W) | |||||
| 67mm (H) | |||||
| 468g |
LCD
12
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-812X | Image: Blood pressure monitor | 113.5mm (L) | |||
| 92mm (W) | |||||
| 48mm (H) | |||||
| 418g | BA-812 | Image: Blood pressure monitor | 113.5mm (L) | ||
| 92mm (W) | |||||
| 48mm (H) | |||||
| 418g | |||||
| BA-813X | Image: Blood pressure monitor | 115.3mm (L) | |||
| 92mm (W) | |||||
| 48mm (H) | |||||
| 412g | BA-813 | Image: Blood pressure monitor | 115.3mm (L) | ||
| 92mm (W) | |||||
| 48mm (H) | |||||
| 412g |
13
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-821X | Image: Blood pressure monitor with LCD screen showing readings, with labels for 'Set', 'Power', and 'Memory' buttons. | 150mm (L) | |||
| 100mm(W) | |||||
| 70mm (H) | |||||
| 610g | |||||
| BA-822X | Image: Blood pressure monitor with LCD screen, with labels for 'LCD', 'Memory', and 'Power' buttons. | 153mm (L) | |||
| 90mm(W) | |||||
| 58mm (H) | |||||
| 380g |
14
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Model | |||||
| Name | Appearance Picture | Size and | |||
| Weight | Model Name | Appearance Picture | Size and | ||
| Weight | |||||
| BA-823X | Image: Blood pressure monitor with arm cuff. The display reads 120/90. Labels point to LCD, Set, Power, and Memory. | 140mm (L) | |||
| 95mm(W) | |||||
| 70mm (H) | |||||
| 420g | |||||
| BA-826X | Image: Blood pressure monitor with arm cuff. The display reads 120/80. Labels point to LCD, Set, Memory, and Power. | 140mm (L) | |||
| 115mm(W) | |||||
| 60mm (H) | |||||
| 500g |
15
8. Conclusion
The subject device AGE Automatic Upper Arm Blood Pressure Monitor has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.