Who is the manufacturer of Arm automatic blood pressure monitor?

Shenzhen Pump Medical System Co., Ltd. submitted the Special clearance for Arm automatic blood pressure monitor (K161708).

What is the FDA product code for Arm automatic 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 Arm automatic blood pressure monitor?

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

Arm automatic blood pressure monitor

K161708 · Shenzhen Pump Medical System Co., Ltd. · DXN · Nov 22, 2016 · Cardiovascular

Device Facts

Record ID	K161708
Device Name	Arm automatic blood pressure monitor
Applicant	Shenzhen Pump Medical System Co., Ltd.
Product Code	DXN · Cardiovascular
Decision Date	Nov 22, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

Arm automatic blood pressure monitor, model: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter.

Device Story

Device is an automatic arm blood pressure monitor for home/over-the-counter use. It uses an air pump to inflate a cuff around the upper arm, compressing the artery. A pressure sensor collects cuff pressure, converting it to a digital signal for the CPU. Software calculates systolic/diastolic blood pressure and pulse rate using an oscillometric algorithm. Output is displayed on a TN-LCD screen. The device helps users monitor blood pressure at home, facilitating self-management of cardiovascular health. It operates on battery or AC adapter power.

Clinical Evidence

No clinical data. The manufacturer states that because the subject device is technically identical to the predicate regarding blood pressure measurement technology, clinical validation per ANSI/AAMI/ISO 81060-2:2009 is unnecessary.

Technological Characteristics

Oscillometric measurement principle. Power: 4 AA batteries or AC adapter (100-240V). Display: TN-LCD. Cuff size: 22cm-44cm. Software: Moderate level of concern. Testing performed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-30.

Indications for Use

Indicated for measuring systolic, diastolic blood pressure and pulse rate of an adult individual using a non-invasive oscillometric technique with an inflatable cuff (22cm-44cm) wrapped around the single upper arm.

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

Arm automatic blood pressure monitor, Model: BE6034, BE6134 (K151258)

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, with a ribbon-like element flowing beneath them. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Shenzhen Pump Medical System Co., Ltd Ms. Migo Yang Clinical Registration Specialist 2/f. M-7 Sinosteel Building. Maqueling Estate. Hi-tech Industrial Park Nanshan District, Shenzhen, 518057 CN Re: K161708 > Trade/Device Name: Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF6002, BF6102, BF1205, BF1215, BF1213, BF6051, BF6151, BF6043, BF6143, BF1204,BF1214, BF6023L, BF6123L, BF6048L, BF6148L, BF6053, BF6153, BF6055 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 23, 2016 Received: June 21, 2016 Dear Ms. Migo Yang, 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 {1}------------------------------------------------ Page 2 - Ms. Migo Yang 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 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 yours, Mada Yellen 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) K161708 #### Device Name Arm automatic blood pressure monitor, Model: BF3202, BF3212, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6148L, BF6053,BF6153, BF6055; #### Indications for Use (Describe) It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable sizes: 22cm~44cm (8.7in~17.3in)) is wrapped around the single upper arm. 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) #### 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}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: _K161708 #### Submitter's Identification: 1. SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. 2/F, M-7 Sinosteel Building, Maqueling Estate, Hi-Tech Industrial Park, Nanshan District, Shenzhen, PEOPLE'S REPUBLIC OF CHINA Contact: Xie Qiongyu Tel:86-0755-26710795 Fax:86-0755-26498210 E-mail:xieqy@bpump.com.cn ## 2. Name of the Device: Trade Name: Arm automatic blood pressure monitor Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153,BF6055; Regulation Description: Non-invasive blood pressure measurement system. Regulation Number: 21 CFR 870.1130 Regulation Class: II Product Code: DXN Review Panel: Cardiovascular ## 3. Information for the 510(k) Cleared Device(Predicate device): Arm automatic blood pressure monitor, Model: BE6034, BE6134, K151258, SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. ## 4. Description of the device Arm automatic blood pressure monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with {4}------------------------------------------------ pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate. The arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; has the same basic principles, main function, performance and intended use, and they are consistent in product structure and material. ## 5. Intended Use: Arm automatic blood pressure monitor, model: BF3202,BF3212, BF6002,BF6102, BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204.BF1214. BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. ## 6. Indications for Use: Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102, BF1205,BF1215, BF1213, BF6051,BF6151, BF6043,BF6143, BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; is intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. ## 7. Comparison to the 510(k) Cleared Device (Predicate device): The subject device, Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002.BF6102. BF1205.BF1215. BF1213. BF6051.BF6151. BF6043.BF6143. BF1204,BF1214, BF6023L,BF6123L, BF6048L,BF6148L, BF6053,BF6153, BF6055; and the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 uses the same oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Upper arm cuff is inflated automatically by air pump and the pressures are transferred via tubing to a sensor in the unit. They differ by the appearance, the way of energy supply as well as PCB. The appearance of subject device is different from predicate device; The only way of energy supply of predicate device is battery while the way of energy supply of subject device can be both battery and adapter. The PCB of subject device has been updated. But those differences do not affect the accuracy or normal use of this device because they use the same fundamental scientific technology based on clinical declaration of identity and the declaration of clinical identity. The subject device: Arm automatic blood pressure monitor, Model: BF3202,BF3212, BF6002,BF6102,BF1205,BF1215,BF1213,BF6051,BF6151,BF6043,BF6143, BF1204,BF1214,BF6023L,BF6123L,BF6048L,BF6148L,BF6053,BF6153,BF6055; {5}------------------------------------------------ uses the same oscillometric method as the predicate device: Arm automatic blood pressure monitor, Model: BE6034, BE6134 to determinate the systolic and diastolic blood pressure and pulse rate. They have the same function and intended use. Based upon the aforementioned information, these devices are substantially equivalent. Please refer to table below for comparison. {6}------------------------------------------------ | (Subject Devices:BE6034,BE6134,BF3202,BF3212,BF6002,BF6102,BF1213) | | | | | | | | | | | |--------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------|--| | | | Model | | | | | | Comparison | | | | No | Items | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | | | 1 | Manufa cturer | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | Identical | NA | | | 2 | Intende d Use | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | Identical | NA | | | 3 | Indicati ons for Use | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | It is intended for measuring systolic, diastolic blood pressure and pulse rate of an adult over the counter. | Identical | NA | | | | | | | | Model | | | Comparison | | | | No | Items | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | | | 4 | Patient populati on | Adult | Adult | Adult | Adult | Adult | Adult | Identical | NA | | | 5 | Environ ment of use | Home | Home | Home | Home | Home | Home | Identical | NA | | | 6 | Measuri ng Principl e | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Identical | NA | | | 7 | Measur ement Range | Pressure: 0mmHg~280mm Hg (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Pressure: 0mmHg~280mm Hg (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Pressure: 0mmHg~280mm Hg (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Pressure: 0mmHg~280mm Hg (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Pressure: 0mmHg~280mmH g (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Pressure: 0mmHg~280m mHg (0kPa~37.3kPa) Pulse: 40 bpm ~180 bpm | Identical | NA | | | 8 | Accurac y | Pressure: ±3mmHg(±0.4kPa ) Pulse: ±5% | Pressure: ±3mmHg(±0.4 kPa) Pulse: ±5% | Pressure: ±3mmHg(±0.4kPa ) Pulse: ±5% | Pressure: ±3mmHg(±0.4kPa ) Pulse: ±5% | Pressure: ±3mmHg(±0.4kPa ) Pulse: ±5% | Pressure: ±3mmHg(±0.4k Pa) Pulse: ±5% | Identical | NA | | | 9 | Display | TN-LCD Digital Display | TN-LCD Digital Display | TN-LCD Digital Display | TN-LCD Digital Display | TN-LCD Digital Display | TN-LCD Digital Display | Identical | NA | | | 10 | Memor y | 2 Memory sets, 60 readings each set. | 2 Memory sets, 60 readings each set. | 2 Memory sets, 60 readings each set. | 2 Memory sets, 60 readings each set. | 2 Memory sets, 60 readings each set. | 2 Memory sets, 60 readings each set. | Identical | NA | | | 11 | Power Source | 4 AA Alkaline battery | 4 AA Alkaline battery or AC Adapter (Input: AC 100-240 V, 50/60Hz,400m A; Output : D.C. 6.0V, 0.5A;) | 4 AA Alkaline battery or AC Adapter (Input: AC 100- 240 V, 50/60Hz,400mA; Output : D.C. 6.0V, 0.5A;) | 4 AA Alkaline battery or AC Adapter (Input: AC 100- 240 V, 50/60Hz,400mA; Output : D.C. 6.0V, 0.5A;) | 4 AA Alkaline battery or AC Adapter (Input: AC 100- 240 V, 50/60Hz,400mA; Output : D.C. 6.0V, 0.5A;) | 4 AA Alkaline battery or AC Adapter (Input: AC 100- 240 V, 50/60Hz,400m A; Output : D.C. 6.0V, 0.5A;) | Different | NA | | | | Items | Model | | | | | | | Comparison | | | No | | BE6034, BE6134 | BF3202 | BF3212 | BF6002 | BF6102 | BF1213 | Result | Note | | | 12 | Broadca st Functio n | BE6034: YES; BE6134: No | No | No | No | No | No | Different | NA | | | 13 | Operati ng Environ ment | Temperature: +5℃~+40℃; Humidity: 15%- 93% Pressure: 70.0kPa ~106.0kPa Altitude: ≤ 3 000 m | Temperature: +5℃~+40℃ Humidity : 15%-93% Pressure: 70.0kPa~ 106.0kPa Altitude: < 3 000 m | Temperature: +5℃~+40℃; Humidity: 15%- 93% Pressure: 70.0kPa ~106.0kPa Altitude: ≤ 3 000 m | Temperature: +5℃~+40℃; Humidity: 15%- 93% Pressure: 70.0kPa ~106.0kPa Altitude: ≤ 3 000 m | Temperature: +5℃~+40℃; Humidity: 15%- 93% Pressure: 70.0kPa ~106.0kPa Altitude: ≤ 3 000 m | Temperature: +5℃~+40℃ Humidity: 15%-93% Pressure: 70.0kPa~ 106.0kPa Altitude: ≤ 3 000 m | Identical | NA | | | 14 | Storage and Transpo rt Environ ment | Temperature: - 25℃~+70℃; Humidity: 10% ~95% Pressure:50.0kPa ~106.0kPa | Temperature: -25°C ~ +70°C Humidity : 10%~95% Pressure:50.0k Pa~106.0kPa | Temperature: - 25°C ~ +70°C ; Humidity: 10% ~95% Pressure:50.0kPa ~106.0kPa | Temperature: - 25°C ~ +70°C ; Humidity: 10% ~95% Pressure:50.0kPa ~106.0kPa | Temperature: - 25℃~+70℃; Humidity: 10%~ 95% Pressure:50.0kPa ~106.0kPa | Temperature: - 25℃~+70℃; Humidity: 10%~95% Pressure:50.0kP a~106.0kPa | Identical | NA | | | 15 | Weight | 360g (Without batteries) | 275g(without batteries) | 275g(without batteries) | 293g(without batteries) | 293g(without batteries) | 314g(without batteries) | Different | NA | | | 16 | Size | 140 mm×116mm×81 mm | 138mm×110m m×68mm | 138mm×110mm× 68mm | 140mm×110mm× 70mm | 140mm×110mm× 70mm | 150mm×110m m×77mm | Different | NA | | #### Table 1. Comparison of Product Specification (Subject Deviceses:BF3202,BF3212,BF6002,BF6102,BF1213) {7}------------------------------------------------ {8}------------------------------------------------ ## Table 2. Comparison of Product Specification (Subject Deviceses:BF1205,BF1215,BF6051,BF6151,BF6055) | No | Items | Model | | | | | | Comparison | | |----|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------| | | | BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note | | 1 | Manufacturer | SHENZHEN PUMP MEDICAL SYSTEM | SHENZHEN PUMP MEDICAL SYSTEM | SHENZHEN PUMP MEDICAL SYSTEM | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM CO.,LTD. | SHENZHEN PUMP MEDICAL SYSTEM | Identical | NA | | | | Model | | | | | | Comparison | | | No | Items | BE6034, BE6134 | BF1205 | BF1215 | BF6051 | BF6151 | BF6055 | Result | Note | | | | CO.,LTD. | CO.,LTD. | CO.,LTD. | | | CO.,LTD. | | | | 2 | Intended Use | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm. | It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non- invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm to 44cm (8…