Portable ECG Monitor (ECG3)

K172862 · Andon Health Co, Ltd. · DSH · Jul 24, 2018 · Cardiovascular

Device Facts

• Record ID: K172862
• Device Name: Portable ECG Monitor (ECG3)
• Applicant: Andon Health Co, Ltd.
• Product Code: DSH · Cardiovascular
• Decision Date: Jul 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The ECG3 is intended for use in a community hospital or at home and it is a dynamic electrocardiogram measurement system. It is designed to measure and record ECG data of an adult individual in the long term by using a technique in which an electrode was pasted on the chest.

Device Story

Portable ECG Monitor (ECG3) is a dynamic ECG measurement system for long-term recording. Device uses chest-pasted electrodes to capture ECG signals from adult patients. Used in community hospitals or home settings; operated by patients or healthcare providers. Device records ECG data for later review by clinicians to assist in diagnosing transient cardiac symptoms. Provides continuous monitoring capability to capture intermittent events; aids clinical decision-making by providing long-term cardiac rhythm data.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance evaluation.

Technological Characteristics

Dynamic ECG measurement system; chest-pasted electrode interface; portable form factor; intended for long-term recording; software-based data processing.

Indications for Use

Indicated for adult patients, asymptomatic or symptomatic (palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain, anxiety), requiring long-term ECG monitoring.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

July 24, 2018

Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street Ya An Road, Nankai District Tianjin, 300190 Cn

Re: K172862

Trade/Device Name: Portable ECG Monitor (model ECG3) Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: June 8, 2018 Received: June 14, 2018

Dear Liu Yi:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ditora Castillo

**For**

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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## Indications for Use

510(k) Number (if known) K172862

Device Name

Portable ECG Monitor (ECG3)

Indications for Use (Describe)

The ECG3 is intended for use in a community hospital or at home and it is a dynamic electrocardiogram measurement system. It is designed to measure and record ECG data of an adult individual in the long term by using a technique in which an electrode was pasted on the chest.

The ECG3 Portable ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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