(391 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is for measuring blood pressure, not treating any medical condition.
No
The device measures blood pressure and pulse rate, which are physiological parameters. While these measurements can be used by a healthcare professional to assist in diagnosis, the device itself simply provides data and does not interpret that data to identify a disease, condition, or state of health.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" and mentions "inflation and measurement," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Electronic Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using an oscillometric technique. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate via a non-invasive technique. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the Electronic Blood Pressure Monitor is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Electronic Blood Pressure Monitor is intended to measure the systolic 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 to
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human profile. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2017
Shenzhen Pango Electronic Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120
Re: K161845
Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 3, 2017 Received: June 27, 2017
Dear Diana Hong:
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
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Part 807); labeling (21 CFR Part 801); medical device 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,
M.A. Hilleman
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161845
Device Name Electronic Blood Pressure Monitor
Indications for Use (Describe)
The Electronic Blood Pressure Monitor is intended to measure the systolic 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 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."
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161845
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- Date of Preparation: 7/11/2017
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- Sponsor Identification
Shenzhen Pango Electronic Co.,Ltd.
No.25, 1st Industrial Park, Fenghuang Road, Xikeng, Henggang, Longgang District, Shenzhen, Guangdong, 518115, China.
Establishment Registration Number: 3006792041
Contact Person: Ms. Xiaoyun Yang Position: Vice General Manager Tel: +86-755-33825988 Fax: +86-755-33825989 Email:sales@pan-go.com
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- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
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- Identification of Proposed Device
Trade Name: Electronic Blood Pressure Monitor; Common Name: Wrist Blood Pressure Monitor; PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, Models: PG-800A36 and PG-800A37
- Identification of Proposed Device
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Regulatory Information Classification Name: Noninvasive blood pressure measurement system Classification: 2 Product Code: DXN; Regulation Number: 21 CFR 870.1130; Review Panel: Cardiovascular;
Intended Use Statement:
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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
The patient population does not include adolescents aged 12 to