ELECTRONIC BLOOD PRESSURE MONITOR

K102920 · Shenzhen Pango Electronic Co., Ltd. · DXN · Oct 15, 2010 · Cardiovascular

Device Facts

• Record ID: K102920
• Device Name: ELECTRONIC BLOOD PRESSURE MONITOR
• Applicant: Shenzhen Pango Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

PG-800A 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.

Device Story

PG-800A is a battery-powered, automatic, non-invasive wrist blood pressure monitor. Device uses oscillometric technique to measure systolic/diastolic blood pressure and pulse rate. Intended for adult use in clinical or home settings. User wraps inflatable cuff around wrist; device automatically inflates/deflates to capture pressure oscillations. Output displayed on screen; includes data storage and WHO blood pressure classification indicator. Healthcare providers or patients use output to monitor blood pressure trends and manage hypertension. Benefits include convenient, portable, non-invasive blood pressure tracking.

Clinical Evidence

Performance and clinical verification testing conducted per ANSI/AAMI SP10:2002+A1:2003+A2:2006. Biocompatibility testing performed per ISO 10993-5:2006 and ISO 10993-10:2002+AMD:2006. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Battery-powered, automatic oscillometric wrist monitor. Materials: Nylon (cuff) and ABS (housing). Dimensions accommodate 13.5-19.5 cm wrist circumference. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ANSI/AAMI SP10 (performance), ISO 10993 (biocompatibility).

Indications for Use

Indicated for adult patients with wrist circumference 13.5-19.5 cm for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via oscillometric technique. Suitable for use in medical facilities or home settings.

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

• KD-795 Blood Pressure Monitor (K070826)

Submission Summary (Full Text)

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## K102920

OCT 1 5 2010

## PANGAO®

·

Premarket Notification promission Promission
Traditional Sec. 510(L) Submission
PG-800A Ellectronic Blood Pressure Monitor
Sec. III 510(k) Summary

OCT 15 2016

IH-1

# Sec. III 510(k) Summary

| This 510(k) Summary is prepared per the request of 21 CFR 807.92. The Assigned 510(k) Number is: | |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date | 20 JUL 2010 |
| Sponsor | Shenzhen Pango Electronic Co., Ltd |
| | No.25, 1st Industrial Park, Fenghuang Road, Xikeng Village, Henggang Town, |
| | Longgang District, Shenzhen, Guangdong, 518115, China |
| | Contact Person: Ms. Xiaoyun Yang, Vice General Manager |
| | T: [phone] F: [phone] E: [e-mail] |
| Submission | MS. Diana Hong / MR. Lee Fu |
| Correspondent | Shanghai Mid-Link Consulting Co., Ltd |
| | P.O.BOX 237-023, Shanghai, 200237, China |
| Proposed Device | Electronic Blood Pressure Monitor, PG-800A |
| Classification | System, Measurement, Blood-pressure, Non-invasive DXN 21 CFR 870.1130 Class II |
| Intended Use | PG-800A 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. |
| Device Description | The proposed device, PG-800A Electronic Blood Pressure Monitor, is a battery driven automatic |
| | non-invasive blood pressure monitor. It 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 device has the data storage function. It has an bar indicating function, which can |
| | indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood |
| | pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. |
| Testing | Electric Safety per IEC 60601-1:1988+A1:1991+A2:1995 / EMC per IEC 60601-1-2:2001+A1:2004 |
| | Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006 |
| | Biocompatibility per ISO 10993-5:2006 / ISO 10993-10:2002+AMD:2006 |
| Predicate Device | KD-795 Blood Pressure Monitor as cleared in K070826 |
| SE Conclusion | The proposed device, PG-800A Electronic Blood Pressure Monitor, measures the blood pressure via |
| | same principle, oscillometric, at the same site, wrist, as the predicate device. Both of them are |
| | driven by batteries. The patient contact materials of both are Nylon and ABS. Therefore, the |
| | proposed device, PG-800A Electronic Blood Pressure Monitor, is claimed to be Substantially |
| | Equivalent (SE) to the predicate device, KD795 Blood Pressure Monitor as cleared in K070826, in |
| | aspect of safety and effectiveness |

Shenzhen Pango Electronic Co., Ltd
Report SN: SHA01420100715-01

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Pango Electronic Co., Ltd. c/o Mr. Ned Devine Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062

OCT 1 5 2010

Re: K102920

Trade/Device Name: Electronic Blood Pressure Monitor, Model PG-800A Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: September 20, 2010 Received: October 1, 2010

Mr. Devine:

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.

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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Page 2 - Mr. Ned Devine

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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PANGAO®

Premarket Notification Traditional Sec. 510(k) Submission PG-800A Electronic Blood Pressure Monitor Sec. II Indication for Use

1 5 2010 OCT

:

Sec. II Indication for Use Statement

510(k) Number:

Device Name: PG-800A Electronic Blood Pressure Monitor

Indications for Use:

PG-800A Electronic Blood Pressure Monitor is intended to measure the systelic 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

Page _ I_ of

510(k) Number k102920

Shenzhen Pango Electronic Co., Ltd Report SN: SHA01420100715-01

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