Happy Health Blood Pressure Monitor

K254000 · Happy Health, Inc. · DXN · Sep 3, 2026 · Cardiovascular

Device Facts

• Record ID: K254000
• Device Name: Happy Health Blood Pressure Monitor
• Applicant: Happy Health, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 3, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring. The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting. The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with arrhythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud's syndrome), under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion.

Device Story

SaMD; derives systolic/diastolic blood pressure (mmHg) from multi-modal physiological inputs (PPG, EDA, Accelerometer, Skin Temperature) collected by compatible FDA-cleared hardware (Happy Ring Health Monitoring System). Operates via signal processing and biophysics; no machine learning; no cuff calibration or demographic initialization required. Used in home or clinical settings by patients. Data transferred via mobile app to cloud-based API/storage for processing. Output displayed to user; intended for measurement/display only; no diagnostic function. Benefits include non-invasive, calibration-free blood pressure monitoring.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2018+A1+A2 and IEEE 1708a-2019. Study included 85 subjects (850 total determinations) compared against invasive arterial line reference. Results: Diastolic mean error 0.12 mmHg (SD 3.16/1.55); Systolic mean error 0.81 mmHg (SD 6.09/2.76). Device met all acceptance criteria for ISO 81060-2.

Technological Characteristics

SaMD; multi-modal sensing (PPG, EDA, Accelerometer, Skin Temperature). Signal processing/biophysics-based; no ML. Wireless connectivity (BLE/WiFi) to mobile app and cloud platform. Complies with IEC 62304 (software), ISO 14971 (risk management).

Indications for Use

Indicated for non-invasive blood pressure monitoring in adults aged 22-50. Contraindicated for individuals with arrhythmias (e.g., atrial fibrillation), severe vascular disease, radial-artery abnormalities (e.g., Raynaud's syndrome), those taking vasoactive drugs, or pregnant individuals. Not for use during motion or low perfusion.

Regulatory Classification

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

• G0 Blood Pressure Monitoring System (K250415)

Reference Devices

• LiveOne LM1P (K201302)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG
ADMINISTRATION

September 3, 2026

Happy Health, Inc.
% Rakesh Lal
Regulatory Consultant
Rx Device Consulting
353 Woburn St.
Lexington, Massachusetts 02420

Re: K254000

Trade/Device Name: Happy Health Blood Pressure Monitor
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive blood pressure measurement system
Regulatory Class: Class II
Product Code: DXN
Dated: August 7, 2026
Received: August 7, 2026

Dear Rakesh Lal:

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

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K254000 - Rakesh Lal

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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.

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K254000 - Rakesh Lal

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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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

STEPHEN C. BROWNING -S

CDR 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

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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. | K254000 | ? |
| Please provide the device trade name(s). | | ? |
| Happy Health Blood Pressure Monitor | | |
| Please provide your Indications for Use below. | | ? |
| The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring. The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting. The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with arrhythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud's syndrome), under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion. | | |
| 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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510(k) #: K254000

Prepared on: 2026-08-31

## 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92

### CONTACT DETAILS

Applicant Name: Happy Health Inc.
Applicant Address: 3200 Gradie Kiltz Ln, #301, Austin, TX 78758, USA
Applicant Phone: [phone]
Applicant Contact: Dr. Dustin Freckleton, CEO
Applicant Email: [e-mail]

Correspondent Name: Rx Device Consulting
Correspondent Address: 353 Woburn Street, Lexington, MA 02420, USA
Correspondent Phone: [phone]
Correspondent Contact: Mr. Rakesh Lal
Correspondent Email: [e-mail]

### PROPOSED DEVICE

Device Trade Name: Happy Health Blood Pressure Monitor
Common Name: Noninvasive blood pressure measurement system
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Product Code(s): DXN

### PREDICATE DEVICE

*Primary Predicate*
Device Name: G0 Blood Pressure Monitoring System (K250415)
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Product Code(s): DXN

*Reference Device*
Device Name: LiveOne LM1P (K201302)
Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: 870.1130
Product Code(s): DXN

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510(k) #: K254000

Prepared on: 2026-08-31

## DEVICE DESCRIPTION

The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) that is intended to measure systolic and diastolic blood pressure in adults between the ages of 22 and 50. The device uses physiological data (PPG, EDA, Accelerometry, Skin Temperature) collected from compatible, FDA cleared, sensors and uses this data to determine the user's absolute systolic and diastolic blood pressure, reported in mmHg. The device does not require any form of calibration with a cuff device nor initialization with patient demographics in order to function. The device does not rely on any other patient-specific initialization or otherwise use memory of a previous condition or state to achieve its intended use.

Currently, the only compatible hardware device is the Happy Ring Health Monitoring System, cleared under K240236. This device is FDA cleared for the collection of the input physiological signals. The compatible hardware device comprises a ring worn on the index finger, a cloud-based API and data storage platform, and a set of cloud-based algorithms. Data is transferred between the ring and the cloud-based API using a mobile application.

The device uses a signal processing and biophysics based approach and does not use machine learning based methodologies to calculate blood pressure.

## INTENDED USE / INDICATIONS FOR USE

The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring.

The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting.

The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with arrhythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud's syndrome), under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion.

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510(k) #: K254000

Prepared on: 2026-08-31

# COMPARISON WITH PREDICATE DEVICE & REFERENCE DEVICE

The table below further summarizes the comparison in intended use and technological characteristics.

| Characteristic | Subject Device | Predicate Device (K250415) | Reference Device (K201302) | Comparison |
| --- | --- | --- | --- | --- |
| | Happy Health Blood Pressure Monitor | G0 Blood Pressure Monitoring System | LiveOne LM1P | |
| Regulation | 21 CFR 870.1130 | 21 CFR 870.1130 | 21 CFR 870.1130 | Equivalent |
| Class | II | II | II | Equivalent |
| Product Code | DXN | DXN | DXN | Equivalent |

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510(k) #: K254000

Prepared on: 2026-08-31

| **Indications for Use** | The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring. The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting. The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with | The Aktiia G0 Blood pressure monitoring system consustes of a wrist worn monitor and an oscillometric cuff. The system is intended for measuring blood pressure and pulse rate based on using a Pulse Wave technique in adults aged from 22 to 59 years old with wrist circumference ranging from 14cm to 21 cm following a calibration process (every 24 hours) using the oscillometric blood pressure cuff. The Aktiia G0 Blood pressure monitoring system is intended for spot-checking of adults patient for home use. | The LiveOne is intended to be used in patients who have a need for a non-invasive blood pressure and hemodynamic monitor. The LiveOne is intended to be used on subjects ≥ 27 years old and who have a palpable radial pulse. Software is used to provide data to qualified medical professionals for the purpose of assessing the patient's cardiac health via blood pressure readings taken in a clinical setting by health care professional. LiveOne is intended only for measurement and display; it makes no diagnosis. | **Equivalent** All three devices are regulated under 21 CFR 870.1130, and product code DXN. The subject device is intended for use in home or clinical settings. This is similar to predicate and reference devices. The predicate device can be used in a home setting while the reference device is only intended for use in a clinical setting. Subject, predicate, and reference devices are intended for measurement of systolic and diastolic BP in adults. The minor variations in age ranges does not raise new questions of safety and effectiveness. |
| --- | --- | --- | --- | --- |

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510(k) #: K254000

Prepared on: 2026-08-31

| | arrythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud's syndrome), essential tremor, under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion. | | | |
| --- | --- | --- | --- | --- |

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510(k) #: K254000

Prepared on: 2026-08-31

| **Patient Population** | Adults (aged 22-50) | Adults (aged 22-59) | Adults (aged ≥ 27) | **Equivalent** All devices are intended for use in adult patients. |
| --- | --- | --- | --- | --- |
| **Device Output** | Absolute systolic and diastolic blood pressure | Absolute systolic and diastolic blood pressure Pulse rate | Absolute systolic and diastolic blood pressure Additional hemodynamic parameters | **Equivalent** All devices output systolic and diastolic blood pressure. |
| **Anatomical Location** | Finger | Wrist | Wrist | **Different** While the exact anatomic location is different, all devices measure blood pressure from well established anatomical locations. Differences do not raise new questions of safety and effectiveness |
| **Software** | Complies with IEC 62304 requirements | Complies with IEC 62304 requirements | Complies with IEC 62304 requirements | **Equivalent** |

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510(k) #: K254000

Prepared on: 2026-08-31

| Sensors used in BP calculation | Multi-modal sensors: PPG, EDA, ACC, TEMP | PPG | Pressure Sensor | Different The subject and predicate device both use PPG, but the subject device also uses other, FDA cleared, sensor technologies. Differences do not raise new questions of safety and effectiveness. |
| --- | --- | --- | --- | --- |
| Principle of Operation | Uses multi-modal signals (PPG, EDA, ACC, TEMP) to estimate absolute blood pressure without calibration | Pulse-wave based algorithm | Applanation tonometry and demographic information (weight, height, age, sex) | Different The specific algorithms used to compute BP are different across all the devices. However, all meet specific clinical requirements. This difference does not raise new questions of safety and effectiveness. |
| Communication Technology | Wireless communication with mobile app (BLE/WiFi) | Wireless communication with mobile app (BLE/WiFi) | Wireless communication with mobile app (BLE/WiFi) | Equivalent |

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510(k) #: K254000

Prepared on: 2026-08-31

| **Calibration with cuff** | Not required | Required every 24 hours | Not required | **Different** The predicate device requires cuff calibration every 24 hours. The subject device uses data from other sensors in addition to PPG, to estimate absolute BP without calibration. The reference device also does not require any cuff calibration due to its sensing modality. All devices meet strict accuracy requirements of the measurements. Thus, this difference does not raise new questions of safety and effectiveness. |
| --- | --- | --- | --- | --- |

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510(k) #: K254000

Prepared on: 2026-08-31

# PERFORMANCE TESTING

# *Non-Clinical Testing Summary*

Non-clinical testing of the Happy Health Blood Pressure Monitor included:

- Software V&V testing in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and with IEC 62304
- Cybersecurity in accordance with FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Risk Management in accordance with ISO 14971
- Usability testing in accordance with FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices

# *Clinical Testing Summary*

Clinical validation was performed in accordance with the ISO 81060-2:2018+A1+A2 Standard and the relevant aspects of IEEE 1708a-2019. The procedure defined in ISO 81060-2 was utilized as the device does not rely on input of user demographics, cuff-based calibration, or memory of a previous condition or state to achieve its intended use.

A total of 85 subjects were recruited as part of the clinical investigation. No subjects were excluded from participation. The subjects recruited into the investigation had a range of demographics, including age, blood pressure ranges, ring size, and skin tone. There were no adverse events reported in the investigation.

The invasive method (arterial line) was used to compare the results of the subject device in all 85 subjects, yielding a total of 850 determinations that were compared. All reference measurements and DUT measurements were taken in accordance with the procedure defined in the ISO 81060-2 Standard. The results demonstrated that the Happy Health Blood Pressure Monitor met the acceptance criteria defined in the standard, in terms of mean error and standard deviation of the error satisfying both criterion 1 and criterion 2 of the ISO 81060-2 standard. The table below provides the results of the clinical validation.

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510(k) #: K254000

Prepared on: 2026-08-31

| Measure | Diastolic Blood Pressure | Systolic Blood Pressure |
| --- | --- | --- |
| Number of subjects | 85 | 85 |
| Number of determinations | 850 | 850 |
| Mean Error (criterion 1) | 0.12 mmHg | 0.81 mmHg |
| SD of errors (criterion 1) | 3.16 mmHg | 6.09 mmHg |
| SD of errors (criterion 2) | 1.55 mmHg | 2.76 mmHg |

## CONCLUSION

The Happy Health Blood Pressure Monitor has been shown to be as safe and effective as the predicate device. Both devices have the same intended use and minor differences in the specific indications of the devices do not raise new questions of safety and effectiveness. Furthermore, differences in technological characteristics do not raise new questions of safety and effectiveness. Thus, the Happy Health Blood Pressure Monitor is substantially equivalent to the predicate device.

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