Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
Device Facts
| Record ID | K254119 |
|---|---|
| Device Name | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) |
| Applicant | Shenzhen Xinyan Medical Technology Co.,ltd. |
| Product Code | MWJ · Cardiovascular |
| Decision Date | Sep 11, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
Indications for Use
Wearable ECG Recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from patients aged 18 and older for a maximum recording time of 7 days in a hospital, clinic or home environment. At the end of the recording, the recorded ECG data can be transferred in the ECG Management Software on PC via the USB connection.
Device Story
Wearable ECG recorder captures continuous ECG signals via single-use wearable sensors adhered to patient skin. Device stores data internally (up to 168 hours); data transferred to PC via USB for review in ECG management software. Bluetooth connectivity allows real-time waveform display on PC to verify proper sensor fitment during application. Operated by patients or healthcare professionals in clinical or home environments. Output consists of raw ECG waveforms for clinician interpretation; device does not perform automated diagnostic analysis. Benefits include ambulatory cardiac monitoring for clinical assessment.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, 60601-1-11, 60601-2-47), EMC (IEC 60601-1-2), biocompatibility (ISO 10993-5, -10, -23), software validation, and usability engineering.
Technological Characteristics
Ambulatory ECG recorder; 1/3/6/9/12-channel configurations. 24-bit A/D conversion; 250Hz sampling rate. Frequency response 0.5-45Hz. Powered by non-rechargeable CR2450 lithium-manganese battery. Connectivity: USB 2.0 for data transfer, BLE 5.3 for setup/verification. Biocompatible materials per ISO 10993. Water-resistant. Software: Moderate level of concern.
Indications for Use
Indicated for patients aged 18 and older requiring continuous ECG recording for up to 7 days in hospital, clinic, or home settings, as directed by a clinician.
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.
Predicate Devices
- Holter System (K151787)
Reference Devices
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG
ADMINISTRATION
September 11, 2026
Shenzhen Xinyan Medical Technology Co.,ltd.
% Cassie Lee
Consultant
Share Info (Guangzhou) Medical Consultant , Ltd.
#1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.
Huangpu District
Guangzhou, Guangdong China
Re: K254119
Trade/Device Name: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
Regulation Number: 21 CFR 870.2800
Regulation Name: Medical Magnetic Tape Recorder
Regulatory Class: Class II
Product Code: MWJ, DRG
Dated: August 13, 2026
Received: August 13, 2026
Dear Cassie Lee:
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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K254119 – Cassie Lee
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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K254119 – Cassie Lee
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(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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
KIMBERLY N.
CROWLEY -S
For: Jennifer Kozen
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
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K254119
Please provide the device trade name(s).
Wearable ECG Recorder (YMHeart XY-12);
Wearable ECG Recorder (YMHeart XY-1201);
Wearable ECG Recorder (YMHeart XY-1202);
Wearable ECG Recorder (YMHeart XY-1203);
Wearable ECG Recorder (YMHeart XY-03);
Wearable ECG Recorder (YMHeart XY-0301);
Wearable ECG Recorder (YMHeart XY-0302);
Wearable ECG Recorder (YMHeart XY-0303)
Please provide your Indications for Use below.
Wearable ECG Recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from patients aged 18 and older for a maximum recording time of 7 days in a hospital, clinic or home environment. At the end of the recording, the recorded ECG data can be transferred in the ECG Management Software on PC via the USB connection.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K254119
# 510(k) Summary for K254119
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
# 1. Submitter's Information
Company Name: Shenzhen Xinyan Medical Technology Co., Ltd.
Address: 1st Building, 501-1 & 501-2, Mitehua&Pukyo Bio Science Park, No. 9 Jinxiu East Road, Laokeng
Community, Longtian Street, Pingshan District, Shenzhen, China
Contact Person (including title): Haibo Zhang (CEO)
Tel: +86 18098974561
Fax: /
Post code: 518122
E-mail: ymheart@xinyancare.com
# Application Correspondent:
Contact Person: Ms. Cassie Lee
Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou,
Guangdong, China
Tel: +86 20 82662446
Email: 382198657@qq.com
# 2. Subject Device Information:
Type of 510(k): Traditional
Common Name: Medical Magnetic Tape Recorder
Classification Name: Electrocardiograph, Ambulatory (Without Analysis)
Trade Name: Wearable ECG Recorder
Model Name: YMHeart XY - 12, YMHeart XY - 1201, YMHeart XY - 1202, YMHeart XY - 1203, YMHeart
XY - 03, YMHeart XY - 0301, YMHeart XY - 0302, YMHeart XY - 0303
Review Panel: Cardiovascular
Product Code: MWJ, DRG
Regulation Number: 21 CFR 870.2800
Regulatory Class: II
# 3. Predicate Device Information
# Primary predicate device
Sponsor: Edan Instruments, Inc.
Trade Name: Holter System
Model: SE-2003 and SE-2012
Common Name: Programmable Diagnostic Computer
Classification Name: Computer, Diagnostic, Programmable
510(K) Number: K151787
Review Panel: Cardiovascular
Product Code: MWJ, DQK
Regulation Number: 21 CFR 870.2800, 21 CFR 870.1425
Regulation Class: II
# Reference Device 1
Sponsor: Sigknow Biomedical Co., Ltd.
Trade Name: EZYPRO ECG Recorder
Model: UG02
1 / 10
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K254119
510(k) Summary
Common Name: Radiofrequency physiological signal transmitter and receiver
Classification Name: Transmitters And Receivers, Physiological Signal, Radiofrequenc
510(K) Number: K213233
Review Panel: Cardiovascular
Product Code: DRG
Regulation Number: 21 CFR 870.2910
Regulation Class: II
# Reference Device 2
Sponsor: Zywie, Inc.
Trade Name: ZywieZ3 Sensor & Adhesive
Common Name: Medical Magnetic Tape Recorder
Classification Name: Electrocardiograph, Ambulatory (Without Analysis)
510(K) Number: K252839
Review Panel: Cardiovascular
Product Code: MWJ
Regulation Number: 21 CFR 870.2800
Regulation Class: II
# 4. Device Description
The wearable ECG sensor is installed on the wearable ECG recorder host and adhered to the surface (skin) of the human body. The wearable ECG recorder samples the ECG signals through the wearable ECG sensor. After the sampling is completed, the wearable ECG recorder is placed in the data box, and the USB cable of the data box is plugged into a computer. The data stored in the wearable ECG recorder device is then transferred to the computer via a USB cable. The transferred data is then displayed on the computer by the ECG management software, allowing the ECG data to be displayed, and printed.
The wearable ECG recorder can also communicate with the computer via Bluetooth, allowing it to display the ECG waveforms recorded by the wearable ECG recorder and helping doctors determine whether the device has been properly fitted on the patient.
The wearable ECG sensor and battery are also single-use.
# 5. Intended Use / Indications for Use
Wearable ECG Recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from patients aged 18 and older for a maximum recording time of 7 days in a hospital, clinic or home environment. At the end of the recording, the recorded ECG data can be transferred in the ECG Management Software on PC via the USB connection.
# 6. Comparison to predicate and reference devices
2 / 10
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K254119
510(k) Summary
| Item | Subject device | Primary predicate device | Reference device 1 | Reference device 2 | Remark |
| --- | --- | --- | --- | --- | --- |
| 510(k) No. | K254119 | K151787 | K213233 | K252839 | -- |
| Proprietary Name | Wearable ECG Recorder | Holter System | EZYPRO ECG Recorder (Model: UG02) | ZywieZ3 Sensor & Adhesive | -- |
| Manufacturer | Shenzhen Xinyan Medical Technology Co.,Ltd. | EDAN INSTRUMENTS, INC | Sigknow Biomedical Co., Ltd. | Zywie, Inc | -- |
| Product Code | MWJ | MWJ | DRG | MWJ | Same Note 1 |
| Intended Use/ Indications for Use | Wearable ECG Recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from patients aged 18 and older for a maximum recording time of 7 days in a hospital, clinic or home environment. At the end of the recording, the recorded ECG data can be transferred in the ECG Management Software on PC via the USB connection. | The SE-2003&SE-2012 Series Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants | EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use,continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection. | The ZywieZ3 Sensor is a wireless device intended for use by healthcare professionals to record and display physiological data for patients requiring outpatient cardiac monitoring, both at home and in healthcare settings. When used with the ZywieZ3 Adhesive, the device captures electrocardiogram (ECG) data and wirelessly transmits it to a separate device- | Similar Note 2 |
3 / 10
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K254119
510(k) Summary
| | | weighing less than 10 kg. It is mainly used for (but not limited to) the following indications: Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. Evaluation of patients for ST segment changes. Evaluation of drug response in patients taking anti-arrhythmic medications. Evaluation of patients with pacemakers. | | such as a mobile phone- for storage, display, and transmission. This is an ambulatory, continuous recording system designed for general patient care. It is not intended for critical care patients and does not replace standard clinical monitoring practices. Instead, it provides physiological data recordings for later review by healthcare professionals. The device is not intended to provide real-time interpretative or diagnostic information. | |
| --- | --- | --- | --- | --- | --- |
| Data Storage Capacity | ≥168h storage time | SE-2012/SE-2012A: 24h(sample rate:1024Hz). 144h(sample rate:128Hz). SE-2003/SE-2003A: 48h(sample rate:1024Hz). | 14 days | 10 days of continuous recording. Charge the device again and reuse it. | Similar Note 3 |
4 / 10
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K254119
510(k) Summary
| | | 192h(sample rate:128Hz) | | | |
| --- | --- | --- | --- | --- | --- |
| Method of Application | Designed adhesive electrode | Off the shelf adhesive electrode | Designed adhesive electrode | Designed adhesive electrode | Similar Note 4 |
| ECG Channel | 1/3/6/9/12 channels | 3 or 12 channels | Channel 1, Single lead | 3-Channel | Similar Note 5 |
| Electrode Position | 1 Lead Electrode Position:Left Sternum, inclined(Self-defined position called"ECG Channel CH1") 3 Lead Electrode Positions:I (CH1) :Below the left and right clavicles, centered ;V1 (CH2): Right of Xiphoid Process on the rib, equivalent to V1;V5 (CH3): Fifth intercostal space on the left anterior axillary line, equivalent toV5 breast lead. 6 Lead Electrode Position:follow 12 Lead Electrode Position connect RA/LA/RL/LL. 9 Lead Electrode Position:follow 12 Lead Electrode Position connect RA/LA/RL/LL/V1/V3/V5 12 Lead Electrode Position:RA,Below clavicle, close to right shoulder; LA,Below clavicle, close to left shoulder; RL,Lower right rib margin over bone; | 5 Electrodes 3 Channels White(COM-) Right Manubrial border of the Sternum. Red(CH1+)Fifth intercostal space on the left anterior axillary line, equivalent to V5 breast lead.Brown(CH2+)Right of Xiphoid Process on the rib, equivalent to V1.Orange(CH3+)Left fifth rib, equivalent to V3.Green (RL) Lower right rib margin over bone. 10 Electrodes 12 Leads RA Below clavicle, close to right shoulder LA Below clavicle, close to left shoulder RL Lower right rib margin over bone. LL Lower left rib margin over bone. V1 Right of Mid-Clavicular line 4th rib V2 Left of Mid-Clavicular line 4th rib V3 In the middle of V2 and V4 V4 Fifth intercostal space on the left mid-clavicular line V5 Left Anterior Axillary | Left Sternum, inclined (Self-defined position called "ECG Channel A") | / | Similar Note 5 |
5 / 10
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K254119
510(k) Summary
| | LL,Lower left rib margin over bone; V1,Right of Mid-Clavicular line 4th rib; V2,Left of Mid-Clavicular line 4th rib; V3,In the middle of V2 and V4; V4,Fifth intercostal space on the left mid-clavicular line; V5,Left Anterior Axillary line, the same level of V4; V6,Left Middle Axillary line, the same level of V4. | line, the same level of V4 V6 Left Middle Axillary line, the same level of V4 | | | |
| --- | --- | --- | --- | --- | --- |
| ECG Resolution | 24-bits | 24 bits | 18 bits, ±5mV | / | Similar Note 6 |
| ECG Sampling rate (Hz) | 250 | 128 /1024 | 256 | / | Similar Note 7 |
| A/D Conversion | 24-bits | 24 bits | / | / | Same |
| Frequency Response | 0.5 Hz to 45 Hz @250 Hz sampling rate | 0.05 Hz to 100 Hz (-3 dB) | / | / | Similar Note 8 |
| Water Resistant | Yes | Yes | Yes | / | Same |
6 / 10
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K254119
510(k) Summary
| Data Transmission | Supports USB 2.0 and BLE 5.3 | Through USB cable or SD card reader | Bluetooth | Bluetooth Low Energy (BLE) | Similar Note 9 |
| --- | --- | --- | --- | --- | --- |
| Power source | CR2450, Lithium-manganese coin cell battery, not rechargeable | 1 AAA alkaline battery, LiFe or Ni-MH battery | 360 mAh lithium battery (Rechargeable battery) | Rechargeable battery | Similar Note 10 |
| Weight (g) | ≤ 25g (excluding Wearable ECG Sensor) | SE-2003/SE-2012: 50g (excluding battery), ±5g SE-2003A/SE-2012A: 75g (excluding battery), ±5g | 20g | 27 gm | Similar Note 11 |
| Dimensions (mm) | Length: 50.5±1.0mm Width: 34.7±1.0mm Height: 10.5±1.0mm | SE-2003/SE-2012: 76mm×49mm×16mm, ±2 mm SE-2003A/SE-2012A: 92mm×56mm×20mm, ±2 mm | 47 (L) x 32 (W) x 12 (H) mm | / | Similar Note 11 |
| Biocompatibility | -In vitro cytotoxicity -Skin irritation -Skin sensitization | -Cytotoxicity -Skin Sensitization -Skin Irritation | -In Vitro Cytotoxicity Test -Intracutaneous Irritation -Skin Sensitization | -In Vitro Cytotoxicity Test -Intracutaneous Irritation -Skin Sensitization | Same |
| Electrical Safety | IEC 60601-1 IEC 60601-1-11 IEC 60601-2-47 | IEC 60601-1 IEC 60601-2-47 | IEC 60601-1 IEC 60601-1-11 IEC 60601-2-47 | IEC 60601-1 IEC 60601-1-11 IEC 60601-2-47 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
7 / 10
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K254119
510(k) Summary
# Comparison in Detail(s):
# Note 1:
The predicate device software includes analysis and diagnostic capabilities, while the subject device software does not, it would not affect substantial equivalence. Even with automatic analysis, it still needs to be confirmed by professionals in the end
# Note 2:
The product structure is identical, comprising a recorder and software. The predicate device software includes analysis and diagnostic capabilities, while the subject device software does not, it would not affect substantial equivalence. The subject device same as reference devices 2 and 3, does not have analytical functions and only records, stores, and displays continuous electrocardiogram data. Therefore, the expected use description is similar and will not affect substantial equivalence.
# Note 3:
The storage range of the predicate device includes the storage time of the test device. And the subject device validation and performance tests demonstrate that it would not affect substantial equivalence.
# Note 4:
The subject device has exclusive electrode, and the function of exclusive electrode has been tested. The substantial equivalence has been demonstrated.
# Note 5:
The connection method of the leads complies with IEC and AHA, and both 6 Lead and 9 Lead are connected based on 12 Lead, which is the same as Predicate device; The lead connection method is the same as reference device 1;The subject device supports 1-lead, which are applied to the similar position as the subject device was used to support the technological characteristic. 3 Lead is also a standard lead, similar to reference devices 2 and 3. The relevant evaluation and tests demonstrate the subject device is substantially equivalent to the predicate.
# Note 6:
Both are more than double the highest useful frequency component (40Hz). Performance tests show that it meets the requirements and the device is substantially equivalent to the predicate.
# Note 7:
Comparing the declared product with Predicate device, the sampling rate is within its range, and compared with Reference device 1, the sampling rate is close. And the software validation and performance tests demonstrate that it would not affect safety and effectiveness.
# Note 8:
The subject device used lower Frequency Response in device for adjustable Wearable. Suitable for most daily usage needs. And the software validation and performance tests demonstrate that it would not affect substantial equivalence.
# Note 9:
The ECG data export of the subject device and the predicate device are both transmitted through USB cable. The Bluetooth is used to check the wearing condition when wearing, just like the waveform display
8/10
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K254119
510(k) Summary
function on reference device 2, and the technology used is wireless Bluetooth technology, just like reference devices 1 and 3. Therefore, these differences will not affect substantial equivalence.
# **Note 10:**
The difference in battery form has little impact on the performance of the product and can ultimately achieve the specified duration of electrocardiogram data and complies with IEC 60601-1.
# **Note:11**
The size and weight of the devices may not be significant, but they will not affect substantial equivalence.
# **7. Test Summary**
7.1 Non-Clinical Tests Performed
# **1) Electrical safety, and electromagnetic compatibility Test**
Electrical safety and EMC testing were conducted on the proposed device. The device was shown to comply with IEC 60601-1-2:2020 for electromagnetic compatibility, IEC 60601-1:2020, IEC 60601-1-11:2020, IEC 60601-2-47:2012 for electrical safety.
External defibrillation safety assessment: Energy reduction testing was conducted in accordance with IEC 60601-1 Clause 8.5.5.2. Testing was performed on representative 1-lead, 3-lead, and 12-lead sensor configurations. For all patient connections and both polarities, the defibrillation energy delivered to the 100 Ω load with the device connected (E1) was at least 90% of the energy delivered with the device disconnected (E2), ranging from 90.17% to 97.70%. No hazardous failure modes (fire, explosion, or exposure of accessible parts) were identified. The device does not claim defibrillation-proof status; however, patient safety during external defibrillation is assured by compliance with the energy reduction requirements.
# **2) Biocompatibility Test**
Biocompatibility testing was performed on the subject device components in accordance with FDA guidance document entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff" The device was shown to comply with ISO 10993-5, ISO 10993-10 and ISO 10993-23.
# **3) Software verification and validation**
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
# **4) Usability validation**
Usability evaluation was conducted and documented according to FDA's guidance document, "Applying Human Factors and Usability Engineering to Medical Devices". The result of the usability demonstrated by all the users in testing did not show any critical errors. The device has been found to be reasonably safe for the intended users, uses and uses environments.
# **5) Cybersecurity**
Cybersecurity software documentation was created for subject devices according to FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 18, 2018.
9/10
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K254119
510(k) Summary
### 7.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively as the predicate device.
### 8. Date of the summary prepared: September 7, 2026
### 9. Final Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
10/10
