← Product Code [DXN](/productcode/DXN) · K253570 # Blood Pressure Monitor (W06LT) (K253570) _Shenzhen Jamr Technology Co., Ltd. · DXN · May 20, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253570 ## Device Facts - **Applicant:** Shenzhen Jamr Technology Co., Ltd. - **Product Code:** [DXN](/productcode/DXN.md) - **Decision Date:** May 20, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adults by using the wrist cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use. The device is not intended for use in patients with arrhythmias or in pregnant patients. ## Device Story Fully automatic, non-invasive oscillometric blood pressure monitor; wrist-worn cuff with integrated pressure sensor/transducer. Device analyzes arterial pulsations to calculate systolic/diastolic pressure and pulse rate. Results displayed on LED screen; stored in internal memory (120 measurements/user for 2 users). Includes Bluetooth connectivity for data transmission to mobile app (non-medical function). Used in medical facilities or home environments; operated by patients or clinicians. Provides objective BP/pulse data to support clinical decision-making and patient monitoring. ## Clinical Evidence Clinical validation study conducted per ISO 81060-2:2018+A1:2020. Enrolled 85 subjects aged >12 years. Primary endpoints: mean error and standard deviation of differences in systolic and diastolic BP measurements. Results met all ISO 81060-2 limits. No adverse effects reported. ## Technological Characteristics Oscillometric measurement; wrist cuff; ABS housing/keys. Powered by 3.7V/300mAh Li-battery or 5V/1A AC adapter. Type BF applied part. Connectivity: Bluetooth (non-medical). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30. Biocompatibility: ISO 10993-1/-5/-10/-23. ## Regulatory 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 - Wrist Type Blood Pressure Monitor ([K230409](/device/K230409.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 20, 2026 Shenzhen Jamr Technology Co., Ltd. Zhuni Chen RA Manager A101-301, D101-201, Jamr Science & Technology Park # 2 Guiyuan Rd. Guixiang Community Guanlan St., Longhua District Shenzhen, Guangdong 518100 China Re: K253570 Trade/Device Name: Blood Pressure Monitor (W06LT) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 3, 2026 Received: May 4, 2026 Dear Zhuni Chen: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253570 - Zhuni Chen Page 2 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 (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- {2} K253570 - Zhuni Chen Page 3 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, 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 {3} Page 1 of 1 | 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. | K253570 | ? | | Please provide the device trade name(s). | | ? | | Blood Pressure Monitor (W06LT) | | | | Please provide your Indications for Use below. | | ? | | The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adults by using the wrist cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use. The device is not intended for use in patients with arrhythmias or in pregnant patients. | | | | 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) | ? | {4} K253570 # 510(k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92. The assigned 510(k) number is: K253570 # 1. Submitter's information Submitter's Names: Shenzhen Jamr Technology Co., Ltd. Address: A101-301, D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community, Guanlan Street, Longhua District, Shenzhen 518100, PEOPLE'S REPUBLIC OF CHINA Tel: +86-755-85292057 Applicant Contact: Zhuni Chen Applicant Contact Email: RA.dept@jamrmed.com # 2. Device Information Device Trade Name: Blood Pressure Monitor Model(s): W06LT Common Name: Noninvasive blood pressure measurement system Classification name: System, Measurement, Blood-Pressure, Non-Invasive Product Code: DXN Device Class: II Regulation Number: 870.1130 # 3. Predicate Device Information 510(K) Number: K230409 Trade Name: Wrist Type Blood Pressure Monitor Model(s): W05,W1101L Classification name: System, Measurement, Blood-Pressure, Non-Invasive Product Code: DXN Device Class: II Regulation Number: 870.1130 # 4. Device Description The blood pressure monitor is a fully automatic, non-invasive measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the wrist, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LED screen. # 5. Intended Use/Indication for use The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adults of adults by using the wrist cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use. The device is not intended for use in patients with arrhythmias or in pregnant patients. # 6. Comparisons of technological characteristics with the predicate device The substantial equivalence chart is provided as follows: Page 1 of 5 {5} Page 2 of 5 K253570 | Substantial Equivalence Comparison | | | | | --- | --- | --- | --- | | Elements of Comparison | Subject Device | Predicate Device (K230409) | Judgment | | Models | W06LT | W05,W1101L | / | | Company | Shenzhen Jamr Technology Co., Ltd. | Shenzhen Jamr Technology Co., Ltd. | Same | | Device Name | Blood Pressure Monitor | Blood Pressure Monitor | Same | | Product code | DXN | DXN | Same | | Regulation # | 21CFR 870.1130 | 21CFR 870.1130 | Same | | Intended use | The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adults by using the wrist cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use. The device is not intended for use in patients with arrhythmias or in pregnant patients. | This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use. | Same | | Anatomical site | Wrist | Wrist | Same | | Patient population | Adults | Adults | Same | | Measurement Item | SYS, DYS, Pulse rate | SYS, DYS, Pulse rate | Same | | Principle | Oscillometric | Oscillometric | Same | | BP measurement range | Cuff pressure display range:0~295mmHg; Systolic Blood Pressure: 60~230mmHg; Diastolic Blood Pressure: 40~130mmHg | Cuff pressure display range: W05:0~295mmHg; W1101L:0~300mmHg; Systolic Blood Pressure: 60~230mmHg; Diastolic Blood Pressure: 40~130mmHg | Same as W05 | | BP accuracy | ±3mmHg | ±3mmHg | Same | | PR measurement range | 40~199 Beats/Min | W05:40~170 Beats/Min W1101L:40~170 Beats/Min | Similar,refer to Note 1 | | PR measurement accuracy | ±5% of reading | ±5% of reading | Same | {6} | Power supply | Powered by a) d.c. 3.7V/ 300mAh lithium battery; b) AC adapter INPUT: a.c. 100-240V 50/60HZ, OUTPUT: d.c. 5V 1A | For W05: Powered by d.c. 3.0V, 2 x1.5V AAA batteries; For W1101L: Powered by a) d.c. 3.7V/ 300mAh lithium battery; b) AC adapter INPUT: a.c. 100-240V 50/60HZ, OUTPUT: d.c. 5V 1A | Same as W1101L | | --- | --- | --- | --- | | Degree of protection against electric shock | Type BF applied part | Type BF applied part | Same | | Model of operation | Continuous operation | Continuous operation | Same | | Cuff size suitable for arm size | 12.5-21.5cm | 12.5-21.5cm | Same | | Sets of memory | Automatically stores the last 120 measurements for 2 users (total 240) | Automatically stores the last 120 measurements for 2 users (total 240) | Same | | Irregular heartbeat detector | Yes | Yes | Same | | Voice | Yes | Yes | Same | | Operation environment | Temperature: 5°C~40°C; Humidity: 15~90%RH; Atmospheric Pressure:70 kPa~106 kPa | Temperature: 5°C~40°C; Humidity: 15~93%RH; Atmospheric Pressure:70 kPa~106 kPa | Similar,refer to Note 1 | | Transport/Storage environment | Temperature: -20°C ~ +60°C, Humidity: 10%RH ~ 93%RH; Atmospheric Pressure:70 kPa~106 kPa | Temperature: -20°C ~ +70°C, Humidity: ≤ 93%RH; Atmospheric Pressure:70 kPa~106 kPa | Similar,refer to Note 1 | | Performance | Compliance with Compliance with IEC 80601-2-30 | Compliance with Compliance with IEC 80601-2-30 | Same | | Transmit data via Bluetooth to the APP | Yes | No | Different,refer to Note 2 | | Clinical | Compliance with Compliance with ISO 81060-2 | Compliance with Compliance with ISO 81060-2 | Same | | Material | ABS housing and ABS keys | ABS housing and ABS keys | Same | | Biocompatibility | All the patient contacting materials are compliance with ISO 10993-1/-5/-10/-23 | All the patient contacting materials are compliance with ISO 10993-1/-5/-10/-23 | Same | | Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-11 | Compliance with IEC 60601-1 and IEC 60601-1-11 | Same | | EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same | Page 3 of 5 K253570 {7} Note 1: Although there are slight differences in the "Operation Environment", "Transport/Storage Environment" and "PR measurement range" between the subject device and the predicate device, both the subject devices and predicate devices meet the requirements of the standards IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 80601-2-30. Relevant test reports demonstrate that these differences do not impact the safety or effectiveness of the devices. Note 2: There is wireless communication with Bluetooth function low energy on the subject device, this wireless function is not for medical purposes, but an additional function, it can transmit the measurement results to the Bluetooth app for storage. The measurement results are also stored in the Blood Pressure Monitor itself. Therefore, the monitor can achieve medical purposes even if it does not use Bluetooth. Therefore, this function has nothing to do with the clinical performance and safety of the product. Besides, the software validation and performance test and FCC test demonstrated the difference of Bluetooth function does not raise any new performance and safety questions. Conclusion: Based on the comparative analysis provided in this submission, it is concluded that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness. 7. Brief discussions of the non-clinical tests Performance testing: The subject device conforms to the following guidances and standards: - IEC 60601-1: Medical electrical equipment–Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirement for basic safety and essential performance–Collateral standard: Electromagnetic compatibility – Requirements and tests - IEC 80601-2-30: Medical electrical equipment–Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers - IEC 60601-1-11: Medical electrical equipment–Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Biocompatibility testing: The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The biocompatibility testing includes the following tests: - Cytotoxicity - Sensitization - Irritation 8. Brief discussions of clinical tests The device was tested in accordance with ISO 81060-2:2018+A1:2020 (Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type). Clinical study was conducted using appropriately sized cuff, enrolling 85 eligible subjects. The study included participants aged >12 years. Page 4 of 5 K253570 {8} The mean error and standard deviation of differences in systolic and diastolic blood pressure measurements were all within the limits specified by ISO 81060-2:2018+A1:2020. No adverse effects or complications were reported. The test results confirm that the Blood Pressure Monitor fully complies with the requirements of IEC 80601-2-30:2018 and ISO 81060-2:2018+A1:2020. ## Final Conclusion: The subject device maintains the same core technology and indications for use as the predicate device (K230409). The minor differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device (K230409). K253570 --- **Source:** [https://fda.innolitics.com/device/K253570](https://fda.innolitics.com/device/K253570) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com