← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K222887 # Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (K222887) _Famidoc Technology Company Limited · DXN · Apr 10, 2023 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K222887 ## Device Facts - **Applicant:** Famidoc Technology Company Limited - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Apr 10, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric ## Intended Use Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the cuff around the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm). ## Device Story Device is an automatic, wireless, upper-arm blood pressure monitor. It uses an inflatable cuff and an oscillometric method to measure systolic/diastolic blood pressure and pulse rate. The device consists of modular components including a pneumatic flow control module, pressure detection module, and a single-chip microcomputer. The microcomputer controls inflation/deflation, processes amplified/filtered pulse pressure signals via a proprietary algorithm, and calculates measurements. Results are displayed on an LED or LCD screen and stored in memory. Some models include Bluetooth/Wi-Fi for data transmission. The device is intended for use by adults and children (12+ years) in home or clinical settings. Healthcare providers or patients use the output to monitor blood pressure trends, aiding in hypertension management and cardiovascular health assessment. ## Clinical Evidence Clinical validation conducted per ISO 81060-2:2018 using a same-arm sequential method. Study included 85 participants (43 males). A manual mercury sphygmomanometer served as the reference. Results confirmed accuracy within acceptable limits specified by ISO 81060-2. No adverse events or side effects reported. ## Technological Characteristics Oscillometric measurement principle. Modular design with single-chip microcomputer. Power: 3.7V lithium battery or 4xAAA batteries/USB 5V. Display: LED or LCD. Connectivity: Bluetooth/Wi-Fi (select models). Biocompatibility per ISO 10993-5, -10. Safety/EMC compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30. ## 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 - Fully Automatic Electronic Blood Pressure Monitor ([K210770](/device/K210770.md)) ## Related Devices - [K241129](/device/K241129.md) — Upper Arm Electronic Blood Pressure Monitor · Shenzhen Goodlymed Technology Co., Ltd. · Jul 3, 2024 - [K191673](/device/K191673.md) — Upper Arm Blood Pressure Monitor · Famidoc Technology Company Limited · Nov 27, 2019 - [K170605](/device/K170605.md) — Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D · Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Mar 27, 2018 - [K241351](/device/K241351.md) — Blood Pressure Monitor (TMB-2092-G) · Guangdong Transtek Medical Electronics Co., Ltd. · Aug 21, 2024 - [K161712](/device/K161712.md) — Arm automatic blood pressure monitor · Shenzhen Pump Medical System Co., Ltd. · Apr 5, 2017 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 ADMINISTRATION' in blue text. April 10, 2023 Famidoc Technology Company Limited Amos Zou Management Representative No. 212 Yilong Road, Hexi Industrial Zone Jinxia. Changan Town Dongguan, Guangdong 523853 China Re: K222887 Trade/Device Name: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 6, 2023 Received: April 7, 2023 Dear Amos Zou: 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. 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 located 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Aneesh S. Deoras -S for 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K22887 #### Device Name Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor Indications for Use (Describe) Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm). 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) #### 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." {3}------------------------------------------------ # 510(K) SUMMARY This summary of 510(K) safety and effective information is being submitted in accordance with the requirement SMDA and 21 CFR 807.92. ## 1. Submitter of 510(K): | Date of Prepared: | 17/1/2023 | |-------------------|------------------------------------------------------------------------------------------------| | Submitter's Name: | Famidoc Technology Company Limited | | Address: | No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town<br>Dongguan Guangdong 523853 CN | | Contact person: | Amos zou | | TEL: | +(86) -769-8927-2488 | | FAX: | +(86) -769-8927-2498 | | E-mail: | qa@famidoc.com | ## 2.Proposed Device and code: | Device Trade Name: | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood<br>Pressure monitor<br>(Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、<br>FDBP-A8B、FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、<br>FDBP-A9B、FDBP-A9BL、FDBP-A9BT、FDBP-A9BLT、<br>FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT) | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Medical<br>Specialty | Noninvasive blood pressure measurement system. | | Product Code: | DXN | | Regulation number | 21 CRF 870.1130 | | Device Class | 2 | ## 3. Predicate Device: | 510(K) | Trade or Proprietary or Model Name | Manufacturer | |---------|------------------------------------------------------|-----------------------| | K210770 | Fully Automatic Electronic<br>Blood Pressure Monitor | Andon Health Co,.Ltd. | ### 4. Description of Proposed Device: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A7B、FDBP-A7BL、FDBP-A7BT、FDBP-A7BLT、FDBP-A8B、 FDBP-A8BL、FDBP-A8BT、FDBP-A8BLT、FDBP-A9B、FDBP-A9BL、FDBP-A9BT、 {4}------------------------------------------------ FDBP-A9BLT、FDBP-A10B、FDBP-A10BL、FDBP-A10BT、FDBP-A10BLT)includes utilize modular design method. It consists of nine main modules: □ power-on self-test module, system initialization module,sampling data processing and pressure, pulse rate calculation module, display processing module, power detection processing module, data storage module, key scanning processing module, sampling processing module, , wireless function module, and each module communicates through a message queue. □ The blood pressure monitor controls the pneumatic flow control module through singlechipped microcomputer to pressurize the cuff module in order to exceed the lower pressure of patients, the blood being pushed against the artery walls; □ Pneumatic Flow Control Module being directed to release the pressure, while the pressure detection module collect pulse pressure signal and amplify filter; [ amplified filtersignal being read by single-chipped microcomputer for pressure and pulse signal,through unique algorithm to obtain the systolic and diastolic pressure with pulse; □ Single-chipped microcomputer will control the inflation/deflation module to release the pressure after receive measurements; □ in the meanwhile, display the measurements results then stored the values with memory module. ## 5. Intended for Use Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the cuff around the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm). #### 6. Technical and Performance The following table compares the device to the predicate device with basic technological characteristics. {5}------------------------------------------------ 7.Comparison of Technological Characteristics with Predicate Device | Elements of<br>Comparison | Subject Devices | | | | Predicate Device | Comparison<br>Result | |-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Device Name | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | | | | Fully Automatic Electronic<br>Blood Pressure Monitor | / | | Device Model | FDBP-A7BL | FDBP-A7BT | FDBP-A10BL | FDBP-A10BT | KD-5810, KD5810B,<br>KD-5811, KD-5920TL,<br>KD-552 | / | | 510 (k) Number | K222887 | K222887 | K222887 | K222887 | K210770 | / | | Product Code | DXN | DXN | DXN | DXN | DXN | SE | | Regulation No. | 870.1130 | 870.1130 | 870.1130 | 870.1130 | 870.1130 | SE | | Classification | II | II | II | II | II | SE | | Intended Use and indications for Use | | | | | | | | Intended Use | Arm Blood Pressure<br>Monitor/Automatic<br>Wireless Smart Blood<br>Pressure is intended to<br>measure the blood<br>pressure and pulse rate of<br>adults and children at<br>least 12 years of age, at<br>household or medical<br>center. with the cuff<br>around the left upper arm<br>according to the<br>instruction in the user's<br>guide manual(Cuff size<br>220 ~ 420 mm). | Arm Blood Pressure<br>Monitor/Automatic<br>Wireless Smart Blood<br>Pressure is intended to<br>measure the blood<br>pressure and pulse rate of<br>adults and children at<br>least 12 years of age, at<br>household or medical<br>center. with the cuff<br>around the left upper arm<br>according to the<br>instruction in the user's<br>guide manual(Cuff size<br>220 ~ 420 mm). | Arm Blood Pressure<br>Monitor/Automatic<br>Wireless Smart Blood<br>Pressure is intended to<br>measure the blood<br>pressure and pulse rate of<br>adults and children at<br>least 12 years of age, at<br>household or medical<br>center. with the cuff<br>around the left upper arm<br>according to the<br>instruction in the user's<br>guide manual(Cuff size<br>220 ~ 420 mm). | Arm Blood Pressure<br>Monitor/Automatic<br>Wireless Smart Blood<br>Pressure is intended to<br>measure the blood<br>pressure and pulse rate of<br>adults and children at<br>least 12 years of age, at<br>household or medical<br>center. with the cuff<br>around the left upper arm<br>according to the<br>instruction in the user's<br>guide manual(Cuff size<br>220 ~ 420 mm). | Fully Automatic Electronic<br>Blood Pressure Monitor is<br>for use by medical<br>professionals<br>or at home and is a<br>non-invasive blood<br>pressure measurement<br>system intended to<br>measure the diastolic and<br>systolic blood pressures<br>and pulse rate of an adult<br>individual<br>by using a non-invasive<br>technique in which an<br>inflatable cuff is wrapped | SE | | upper arm. The cuff<br>circumference is limited to<br>22cm-48cm. | | | | | | | | Performance Specification | | | | | | | | Measuring<br>Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | Oscillometric Method | SE | | Measuring<br>Range | Systolic: 60-250mmHg<br>Diastolic: 30-195mmHg<br>Pulse: 40-199beats/min | Systolic: 60-250mmHg<br>Diastolic: 30-195mmHg<br>Pulse: 40-199beats/min | Systolic: 60-250mmHg<br>Diastolic: 30-195mmHg<br>Pulse: 40-199beats/min | Systolic: 60-250mmHg<br>Diastolic: 30-195mmHg<br>Pulse: 40-199beats/min | Systolic: 60-260mmHg<br>Diastolic: 40-199mmHg<br>Pulse rate: 40-180<br>beats/min | Similar<br>Note 1 | | Pressure<br>resolution | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | 1 mmHg or 0.1 kPa | SE | | Accuracy | Pressure:<br>±3 mmHg (±0.4kPa)<br>Pulse:±5% | Pressure:<br>±3 mmHg (±0.4kPa)<br>Pulse:±5% | Pressure:<br>±3 mmHg (±0.4kPa)<br>Pulse:±5% | Pressure:<br>±3 mmHg (±0.4kPa)<br>Pulse:±5% | Pressure: ±3mmHg<br>Pulse rate:<br>Less than 60: ±3bpm<br>More than 60 (incl.) : ±5% | Similar<br>Note 2 | | Patient<br>Population | Adult | Adult | Adult | Adult | Adult | SE | | Measurement<br>Site of Body | Upper Arm | Upper Arm | Upper Arm | Upper Arm | Upper Arm | SE | | Inflation and<br>Deflation | Automatic | Automatic | Automatic | Automatic | Automatic | SE | | Memory Size | 2x60 sets record | 2x60 sets record | 2x60 sets record | 2x60 sets record | 4×60 times with time and<br>date stamp | Similar<br>Note 3 | | Indicators | Blood Pressure (Systolic<br>and Diastolic), Pulse,<br>Date, Time, WHO BP<br>Classification Indicating<br>Bar, Low Battery Icon,<br>Heart Icon, Memory | Blood Pressure (Systolic<br>and Diastolic), Pulse,<br>Date, Time, WHO BP<br>Classification Indicating<br>Bar, Low Battery Icon,<br>Heart Icon, Memory | Blood Pressure (Systolic<br>and Diastolic), Pulse,<br>Date, Time, WHO BP<br>Classification Indicating<br>Bar, Low Battery Icon,<br>Heart Icon, Memory | Blood Pressure (Systolic<br>and Diastolic), Pulse,<br>Date, Time, WHO BP<br>Classification Indicating<br>Bar, Low Battery Icon,<br>Heart Icon, Memory | Blood Pressure (Systolic<br>and Diastolic), Pulse,<br>Date, Time, WHO BP<br>Classification Indicating<br>Bar, Low Battery Icon,<br>Heart Icon, Memory | SE | | | | | | K222887 510(k) Summary | | | | | Record<br>Number,Bluetooth<br>symbol | Record<br>Number,Bluetooth<br>symbol | Record<br>Number,Bluetooth<br>symbol | Record Number,Bluetooth<br>symbol | Record Number,Bluetooth<br>symbol | | | Cuff<br>Circumference | 220mm ~420mm | 220mm ~420mm | 220mm ~420mm | 220mm ~420mm | 22cm-30cm,<br>30cm-42cm(Optional),<br>42cm-48cm(Optional),<br>22cm-42cm (Optional) | Similar<br>Note 4 | | Power Battery | 3.7V lithium battery or<br>USB 5V adapter | 4xAAA 1.5V alkaline<br>batteries or USB 5V<br>adapter | 3.7V lithium battery or<br>USB 5V adapter | 4xAAA 1.5V alkaline<br>batteries or USB 5V<br>adapter | 4xAA 1.5V alkaline<br>batteries or DC 6V<br>adapter | Similar<br>Note 5 | | Display | LED Digital Display | LED Digital Display | LCD Digital Display | LCD Digital Display | LCD Digital Display | Similar<br>Note 6 | | | OPERATING&STORAGE CONDITIONS | | | | | | | Operating<br>Environment | Temperature: 5°C~40°C<br>Humidity: 15% RH~90%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: 5°C~40°C<br>Humidity: 15% RH~90%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: 5°C~40°C<br>Humidity: 15% RH~90%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: 5°C~40°C<br>Humidity: 15% RH~90%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: 10°C~40°C<br>Humidity: ≤85%RH<br>Atmospheric pressure:<br>80kPa~105kPa | Similar<br>Note 7 | | Storage<br>Environment | Temperature: -25°C~55°C<br>Humidity: 15% RH~95%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: -25°C~55°C<br>Humidity: 15% RH~95%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: -25°C~55°C<br>Humidity: 15% RH~95%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: -25°C~55°C<br>Humidity: 15% RH~95%<br>RH, No condensation<br>Atmospheric pressure:<br>70kPa~106kPa | Temperature: -20°C~50°C<br>Humidity: ≤85%RH<br>Atmospheric pressure:<br>80kPa~105kPa | Similar<br>Note 8 | | | COMPLIANCE STANDARDS | | | | | | | Electrical Safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Safety Engineering | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Safety Engineering | | Home Use | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | Safety Engineering | | Performance | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | Safety Engineering | | Biocompatibility | All the patient | All the patient… --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K222887](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K222887) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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