Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 14, 2025 Jiangxi AICARE Medical Technology Co., Ltd. Xiao Lizhu Quality Regulations Department Manager No. 6, South Side of Nanhuan Road Qianping Industrial Park, Le'an County Fuzhou, Jiangxi 344300 China Re: K250185 Trade/Device Name: Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 22, 2025 Received: January 22, 2025 Dear Xiao Lizhu: 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 {1} K250185 - Xiao Lizhu Page 2 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 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 QS 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 (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 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. 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 {2} K250185 - Xiao Lizhu Page 3 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, 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (101) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K250185 | | | Device Name Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | | | Indications for Use (Describe) Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia. | | | Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} Jiangxi AICARE Medical Technology Co., Ltd. # 510 (k) Summary This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92. # (1) Applicant information: 510(k) owner's name: Jiangxi AICARE Medical Technology Co., Ltd. Address: No.6, South Side of Nanhuan Road Qianping Industrial Park, Le'an County, Fuzhou City, 344300 Jiangxi Province, China Contact person: Lizhu Xiao Phone number: +86 794 6577516 Fax number: +86 794 6577516 Email: xiaolizhu@spt-tek.com Date of summary prepared: July 11, 2025 # (2) Proprietary name of the device Trade name/model: Electronic Sphygmomanometers ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24 Common name: Noninvasive blood pressure measurement system Regulation number: 21 CFR 870.1130 Product code: DXN Review panel: Cardiovascular Regulation class: Class II # (3) Predicate and reference device > Predicate device | Sponsor | ShenZhen ZhengKang Technology Co., Ltd | | --- | --- | | Device Name and Model | Upper Arm Blood Pressure Monitor Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876 | | 510(k) Number | K191894 | | Product Code | DXN | | Regulation Number | 21CFR870.1130. | | Regulation Class | II | > Reference device | Sponsor | JOYTECH Healthcare Co., Ltd | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd | | --- | --- | --- | | Device Name and Model | Arm-type Fully Automatic | Electronic Blood Pressure | K250185 {5} Jiangxi AICARE Medical Technology Co., Ltd. | | Digital Blood Pressure Monitor Model: DBP-1307b, DBP-1305b, DBP-1318b, DBP-1319b, DBP-1332b, DBP-1333b, DBP-1307b, DBP-1257b, DBP-1358b, DBP-1359b | Monitor : YE620B, YE620D, YE660E, YE660F and YE680B | | --- | --- | --- | | 510(k) Number | K200649 | K200939 | | Product Code | DXN | DXN | | Regulation Number | 21CFR870.1130 | 21CFR870.1130 | | Regulation Class | II | II | # (4) Description/ Design of device: The Electronic Sphygmomanometers, including ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24, is suitable for measurement of systolic blood pressure and diastolic blood pressure of adult person and adolescents 18 to 21 years old with arm circumference ranging from $22\mathrm{cm}$ to $42\mathrm{cm}$ by the oscillometric technique. The error is controlled within the range specified in IEC 80601-2-30 Non-invasive automated monitor. User can select the blood pressure unit mmHg or kPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and cuff. And all models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores $2^{*}99$ sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function. The seven models have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard; only appearance have some difference. # (5) Intended use / indications: Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia. (6) Materials | Component name | Material of Component | Body Contact Category | Contact Duration | | --- | --- | --- | --- | | Cuff | Nylon polyester | Surface skin contact | Less than 24 hours | We have directly purchased cuff from qualified supplier which has obtained Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion". # (7) Technological characteristics and substantial equivalence: K250185 {6} Jiangxi AICARE Medical Technology Co., Ltd. | Item | Proposed device | Predicate device | Reference device1 | Reference device2 | Remark | | --- | --- | --- | --- | --- | --- | | Trade name | Electronic Sphygmomanometers (Model:ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Upper Arm Blood Pressure Monitor (Model:ZK-B868, ZK-B869, ZK-B872, ZK-B876) | Arm-type Fully Automatic Digital Blood Pressure Monitor (Model:DBP-1307b, DBP-1305b, DBP-1318b, DBP-1319b, DBP-1332b, DBP-1333b, DBP-1307b, DBP-1257b, DBP-1358b, DBP-1359b) | Electronic Blood Pressure Monitor : YE620B, YE620D, YE660E, YE660F and YE680B | / | | 510 (k) number | K250185 | K191894 | K200649 | K200939 | / | | Manufacturer | Jiangxi AICARE Medical Technology Co., Ltd. | ShenZhen ZhengKang Technology Co., Ltd. | JOYTECH Healthcare Co., Ltd. | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd | / | | Regulation number | 21 CFR 870.1130 | 21 CFR 870.1130 | 21 CFR 870.1130 | 21 CFR 870.1130 | Same | | Regulation description | Noninvasive blood pressure measurement system | Noninvasive blood pressure measurement system | Noninvasive blood pressure measurement system | Noninvasive blood pressure measurement system | Same | | Product code | DXN | DXN | DXN | DXN | Same | | Class | II | II | II | II | Same | K250185 {7} Jiangxi AICARE Medical Technology Co., Ltd. | Indications for use/ Intended use | Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure of adult person and adolescents age 18 through 21 years of age. It can be used at home. It is contraindicated in pregnant women, including those with preeclampsia. | This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home. | The Full Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age. | Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia) | Similar Note 1 | | --- | --- | --- | --- | --- | --- | | Patient population | Adult and 18 through 21 years of age | Adult | Adult and 12 through 21 years of age | Adult | Similar Note 1 | | Location for use | OTC | OTC | OTC | OTC | Same | | Environment of use | Medical facilities or home | Medical facilities or home | / | household or medical facilities | Same | | Operation principle | Oscillometric | Oscillometric | Oscillometric | Oscillometric | Same | | Measurement rate | Pressure: 0~295mmHg, | Pressure: 0~295mmHg Pulse Rate: 40~195 bpm | Systolic Pressure:60mmHg ~280 mmHg Diastolic Pressure: 30 mmHg ~ 200 mmHg Pulse:30 ~ 180 Beats/Minute | Pressure:0 ~ 300 mmHg Pulses:40 ~ 200beats/min | Similar | | Accuracy | Pressure: ± 3mmHg( ± 0.4kPa), or 2% of the reading | Pressure: ± 3mmHg( ± 0.4kPa) Pulse Rate:±5% | Static Pressure: ±3mmHg Pulse:±5% | Pressure: ± 3mmHg( ± 0.4kPa) Pulse Rate:±5% of reading value | Same | | Display screen | LCD | LCD | LCD | LCD | Same | | Scale selection | mmHg/kPa | mmHg/kPa | mmHg | mmHg/kPa | Same | K250185 {8} Jiangxi AICARE Medical Technology Co., Ltd. | Cuff circumference | 22cm-42cm | 22cm-32cm | 22-36cm | Type A(22cm-32cm, 22cm-45cm optional) Type B A(22cm-32cm, 22cm-45cm optional) | Similar Note 2 | | --- | --- | --- | --- | --- | --- | | Memory | 2*99sets | 2*99 sets | / | Up to 99x2 sets of data | Same | | Power supply | Battery:4AAA batteries(DC 6V) or optional adapter with USB cable(DV5V/500mA) | Battery:4AA batteries (DC6V)-(ZK-B868) 4AAA batteries (DC6V)-(ZK-869/ZK-872/ZK-B876) or optional adapter with USB cable(DV5V/500mA) | For models DBP-1318b, DBP-1257b, DBP-1358b,DBP-1359b:4×1.5V AAA battery or Medical AC adapter (DC 6V,600mA)(recommended, not Provided); For other models:4 × 1.5V AA battery or Medical AC adapter (DC 6V,600mA)(recommended | 4 AA batteries or 6V/600mA AC adater | Same | | Operating Environment | Temperature:+5 °C ~+40°C; Humidity:15 ~ 80%RH Atmospheric pressure: 80 kpa ~ 105 kpa | Temperature:+5 °C ~+40°C; Humidity:15 ~ 80%RH | Temp.: +10 °C ~ +40°C Humidity:15 ~ 93%RH Atmospheric:700hPa~1060hPa | Temperature:+5 °C ~+40°C; Humidity:15 ~ 90%RH | Similar | | Storage Environment | Temperature:-20 °C ~+55°C; Humidity:10 ~ 93%RH | Temperature:-20 °C ~+55°C; Humidity:10 ~ 93%RH | Temp.: -25 °C ~ +55°C Humidity: ≤ 90%RH | Temperature:-20 °C ~+55°C; Humidity:15 ~ 90%RH(no condensation) | Same | | Type of transmission | Non-transmission/Bluetooth | Non-transmission | Bluetooth | / | Similar Note 3 | | Compliance with | ANSI AAMI ES 60601-1; | IEC 60601-1; IEC 60601-1-2; | AAMI/ANSI ES 60601-1 | IEC 60601-1; IEC60601-1-2; | Same | | Compliance with | ANSI AAMI ES 60601-1; | IEC 60601-1; IEC 60601-1-2; | ANSI/ANSI ES 60601-1 | IEC 60601-1; IEC60601-1-2; | Same | K250185 {9} Jiangxi AICARE Medical Technology Co., Ltd. | voluntary standards | IEC 60601-1-2; IEC 60601-1-11; IEC 80601-2-30; ISO 10993-1,-5,10; ISO 81060-2 | IEC 60601-1-11; IEC 80601-2-30; ISO 10993-1,-5,10; ISO 81060-2 | IEC 80601-2-30:2009 IEC 60601-1-11 IEC 60601-1-2 EN 300328 EISI EN 301489-1 EISI EN 301489-17 | IEC60601-1-6; IEC60601-1-11; ANSI AAM IEC80601-2-30; ISO 81060-2 | | | --- | --- | --- | --- | --- | --- | # Comparison in details: Note 1: Although the patient population is a little different between the proposed and predicate device, but it's within the scope of Reference device 1, the difference is insignificant and do not affect safety and effectiveness. And the proposed device has been validated to be in conformity with its claimed range. Note 2: Although the Cuff circumference is a little different between the proposed and predicate device, but it's within the scope of Reference device 2, the difference is insignificant and do not affect safety and effectiveness. And the proposed device has been validated to be in conformity with its claimed range. Note 3: Although the Type of transmission is a little different between the proposed and predicate device, but it's within the scope of Reference device 1, the difference is insignificant and do not affect safety and effectiveness. And the proposed device has been validated to be in conformity with its claimed range. # Conclusion: Electronic Sphygmomanometers is substantially equivalent to the predicate device. # (8)Testing summary: The following performance data is provided in support of the substantial equivalence determination. # Non-Clinical Study: Non-clinical tests were conducted to verify that the proposed device meets the same design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the proposed device complies with the following standards: # Electrical and EMC Safety: The electrical safety and EMC safety testing was performed as per the following standards and passed: > ANSI AAMI ES 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 requirements for basic safety K250185 {10} Jiangxi AICARE Medical Technology Co., Ltd. and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests > 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 ## Performance Data: The performance testing was performed as per the following standards and passed: > IEC 80601-2-30, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers > ISO 81060-2, Non-invasive sphygmomanometers - Part 2: clinical validation of automated measurement type [Including: Amendment 1(2020)] > FDA Guidance No-Invasive Blood Pressure (NIBP) Monitor Guidance ## Software: We have also conducted Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". ## Biocompatibility Testing: The biocompatibility evaluating for the body-contacting component (arm cuff) of this device was conducted in accordance with the "Use of International Standard ISO 10933-1, Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The arm cuff has performed and passed the Biocompatibility test. So we have reason to believe that the arm cuff is safe for the users. The arm cuff complies with the following standards: > ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity > ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization. > ISO 10993-23, Biological Evaluation of Medical Devices - Part 23: Tests for irritation ## FCC Test: > FCC Part15 Subpart C > RF Exposure Evaluation ## Clinical Study: We conducted a comparative clinical study to verify the performance of the proposed device and predicate device as well as a mercury sphygmomanometer according to ISO 81060-2. The study demonstrated a significant correlation in the performance of proposed device and predicate device. The design of the proposed device specifications is substantially the same as the predicate. All the labeling and characteristics of the Electronic Sphygmomanometers are the same as the K250185 {11} Jiangxi AICARE Medical Technology Co., Ltd. predicate device, and most normal blood pressure monitors currently on the market. The proposed device and predicate device both use similar measuring methodologies and components to achieve the measurements. # (9) Conclusion Based on the above analysis and non-clinical/clinical tests performed, it can be concluded that the proposed device Electronic Sphygmomanometers is as safe, as effective, and performs as well as the legally marketed predicate device, K191894, Upper Arm Blood Pressure Monitor Model: ZK-B868, ZK-B869, ZK-B872, ZK-B876. K250185