Who is the manufacturer of AGE Automatic Upper Arm Blood Pressure Monitor?

Ageless Health Industrial Co., Ltd. filed the 510(k) submission for AGE Automatic Upper Arm Blood Pressure Monitor (K153552).

What is the FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AGE Automatic Upper Arm Blood Pressure Monitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AGE Automatic Upper Arm Blood Pressure Monitor?

AGE Automatic Upper Arm Blood Pressure Monitor (K123882).

Who can help prepare an FDA 510(k) submission like AGE Automatic Upper Arm Blood Pressure Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AGE Automatic Upper Arm Blood Pressure Monitor

K153552 · Ageless Health Industrial Co., Ltd. · DXN · Jun 1, 2016 · Cardiovascular

Device Facts

Record ID	K153552
Device Name	AGE Automatic Upper Arm Blood Pressure Monitor
Applicant	Ageless Health Industrial Co., Ltd.
Product Code	DXN · Cardiovascular
Decision Date	Jun 1, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

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.

Device Story

Battery-powered automatic non-invasive blood pressure monitor; uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Input: pressure signals from inflatable upper arm cuff. Processing: automated inflation/deflation and signal analysis to derive BP and pulse. Output: digital display of systolic/diastolic BP, pulse rate, date, time, WHO BP classification bar, and memory records. Used by medical professionals or patients at home. Healthcare providers use output for routine BP monitoring and clinical decision-making. Benefits: enables convenient, non-invasive, self-administered or clinical BP tracking.

Clinical Evidence

Bench testing only. Evaluated per IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 81060-2 (clinical validation of automated measurement). No clinical trial data provided.

Technological Characteristics

Battery-powered (4x AA) oscillometric monitor. Materials: patient-contacting materials tested per ISO 10993-5/10. Connectivity: standalone. Software: embedded firmware. Standards: IEC 60601-1, IEC 60601-1-2, ISO 81060-2.

Indications for Use

Indicated for adult individuals to measure diastolic and systolic blood pressure and pulse rate using a non-invasive oscillometric technique with an inflatable upper arm cuff. Available in six cuff sizes.

Regulatory Classification

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.

Predicate Devices

AGE Automatic Upper Arm Blood Pressure Monitor (K123882)

Related Devices

K172895 — AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 · Ageless Health Industrial Co., Ltd. · Jun 18, 2018
K123882 — AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR · Ageless Health Industrial · Aug 14, 2013
K102988 — ELECTRONIC BLOOD PRESURE MONITOR · Shenzhen Pango Electronic Co., Ltd. · Nov 9, 2010
K200716 — Electronic Blood Pressure Monitor · Shenzhen Pango Electronic Co., Ltd. · Dec 4, 2020
K160349 — Electronic Sphygmomanometer · Guangdong Biolight Meditech Co., Ltd. · Nov 3, 2016

Submission Summary (Full Text)

{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) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <table style="border:none"><tr><td>☐ Registration Use (Part 21 CFR 601 Subpart D)</td><td>☒ One-Time Central Use (21 CFR 601 Subpart G)</td></tr></table> | ☐ 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. # 9. Summary Prepared Date 26 April 2016