Digital Blood Pressure Monitor (Arm Type)

K231245 · Guangdong Genial Technology Co., Ltd. · DXN · Nov 22, 2023 · Cardiovascular

Device Facts

• Record ID: K231245
• Device Name: Digital Blood Pressure Monitor (Arm Type)
• Applicant: Guangdong Genial Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The devices are intended to measure the systolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm ~ 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.

Device Story

Digital Blood Pressure Monitor (Arm Type) measures systolic blood pressure and pulse rate via oscillometric method; utilizes inflatable arm cuff (220-320mm) to detect arterial pressure oscillations; processes signals to calculate blood pressure and pulse; displays results on integrated screen; intended for OTC use by adults >12 years in home or clinical settings; provides immediate feedback for patient monitoring; aids in tracking cardiovascular health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system; arm cuff (220-320mm); digital display; battery-powered; software-controlled signal processing.

Indications for Use

Indicated for adults >12 years old for non-invasive measurement of systolic blood pressure and pulse rate using an arm cuff (220-320mm). Suitable for home or clinical use.

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.

Submission Summary (Full Text)

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November 22, 2023

Guangdong Genial Technology Co., Ltd. % Reanny Wang - General Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community Guangming Street, Guangming District Shenzhen, Guangdong, China 518000

Re: K231245

Trade/Device Name: Digital Blood Pressure Monitor (Arm Type) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 27, 2023 Received: October 27, 2023

Dear Reanny Wang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K231245

#### Device Name

Digital Blood Pressure Monitor (Arm Type)

#### Indications for Use (Describe)

The devices are intended to measure the systolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm ~ 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.

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)

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