(96 days)
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments.
The device supports continuous data collection for monitoring the following physiological parameters:
- Physical movement associated with applications in physiological monitoring
- Activity associated with movement during sleep
EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
EmbraceMini is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is running. The Care App is a component of the FDA cleared Empatica Health Monitoring Platform
The data received is analyzed by one of the Care App software modules, EmpaDSP, which computes the user's physiological parameters.
The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
EmbraceMini is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments.
N/A
FDA 510(k) Clearance Letter - EmbraceMini
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 22, 2025
Empatica S.r.l.
Alberto Poli
Director, Quality & Regulatory Compliance
Via Stendhal, 36
Milan, 20144
Italy
Re: K252981
Trade/Device Name: EmbraceMini
Regulation Number: 21 CFR 882.5050
Regulation Name: Biofeedback device
Regulatory Class: Class II
Product Code: LEL
Dated: September 17, 2025
Received: September 17, 2025
Dear Alberto Poli:
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.
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).
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December 22, 2025
Empatica S.r.l.
Alberto Poli
Director, Quality & Regulatory Compliance
Via Stendhal, 36
Milan, 20144
Italy
Re: K252981
Trade/Device Name: EmbraceMini
Regulation Number: 21 CFR 882.5050
Regulation Name: Biofeedback device
Regulatory Class: Class II
Product Code: LEL
Dated: September 17, 2025
Received: September 17, 2025
Dear Alberto Poli:
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.
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 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).
Page 3
Sincerely,
Patrick Antkowiak -S
for
Jay Gupta
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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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): K252981
Device Name: EmbraceMini
Indications for Use (Describe)
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments.
The device supports continuous data collection for monitoring the following physiological parameters:
- Physical movement associated with applications in physiological monitoring
- Activity associated with movement during sleep
EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Empatica Srl Traditional 510(k) EmbraceMini
EmbraceMini – 510(k)
510(k) Summary
Version 2.0
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Empatica Srl Traditional 510(k) EmbraceMini
510(k) Summary
I. SUBMITTER
| Company Name | Empatica Srl |
|---|---|
| Establishment Registration Number | 3012933969 |
| Contact Person | Alberto Poli, Director, Quality & Regulatory Compliance |
| Contact Person email | apo@empatica.com |
| Address | Via Stendhal, 36 - 20144, Milan, Italy |
| Telephone Number | +39 02 36165068 |
| Date prepared | September 10, 2025 |
II. DEVICE
Trade/Proprietary Name: EmbraceMini
Common/Usual Name: Remote Patient Monitoring System
Primary Product Code:
| Classification Regulation | Classification Name | Device Class | Product Code | Classification Panel |
|---|---|---|---|---|
| 882.5050 | Device, Sleep Assessment | Class II | LEL | Neurology |
III. PREDICATE DEVICES
| Predicate Device | Name | Submitter | Product Code(s) | 510(k) Number |
|---|---|---|---|---|
| Primary | Empatica Health Monitoring Platform | Empatica S.r.l. | MWI, DQA, BZQ, DRG, LEL, GZO, FLL | K230457 |
The predicate has not been subject to a design-related recall.
IV. REFERENCE DEVICE
No reference device has been used for this submission
V. DEVICE DESCRIPTION
EmbraceMini is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is running. The Care App is a component of the FDA cleared Empatica Health Monitoring Platform
The data received is analyzed by one of the Care App software modules, EmpaDSP, which computes the user's physiological parameters.
The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.
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EmbraceMini is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments.
VI. INDICATION FOR USE
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments.
The device supports continuous data collection for monitoring the following physiological parameters:
- Physical movement associated with applications in physiological monitoring
- Activity associated with movement during sleep
EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
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VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The application EmbraceMini is substantially equivalent to the identified predicate devices. The devices have similar Indications for Use, features, technology, and accuracy.
| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Common Name | device, sleep assessment | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | N/A |
| Device Manufacturer | Empatica S.r.l. | Empatica S.r.l. | N/A |
| Device Classification | II | II | N/A |
| 510(k) number | N/A | K230457 | The subject device and the predicate are identical |
| Product Code | LEL | MWI | The subject device has as product code one of the associated product codes of the predicate. |
| Associated Product Code(s) | N/A | DQA, BZQ, DRG, GZO, LEL, FLL | The subject device does not have any associated product code. |
| Intended Use/Indications for Use | EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments. The device supports continuous data collection for monitoring the following physiological parameters: | The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation | The subject device as more limited indication for use, specifically it can only monitor physical movement and activity associated with movement during sleep. This different does not raise additional |
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| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Intended Use/Indications for Use (continued) | • Physical movement associated with applications in physiological monitoring• Activity associated with movement during sleepEmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. | of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:• Pulse Rate,• Blood Oxygen Saturation under no-motion conditions,• Respiratory Rate under no motion conditions,• Peripheral Skin Temperature,• Electrodermal Activity,• Activity associated with movement during sleepThe Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion. | safety or performance concerns. |
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| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Intended Use/Indications for Use (continued) | • Physical movement associated with applications in physiological monitoring• Activity associated with movement during sleepEmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. | of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:• Pulse Rate,• Blood Oxygen Saturation under no-motion conditions,• Respiratory Rate under no motion conditions,• Peripheral Skin Temperature,• Electrodermal Activity,• Activity associated with movement during sleepThe Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion. | safety or performance concerns. |
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| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Intended Use/Indications for Use (continued) | The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making. | ||
| Target Population | Adult | Adult | The subject device and the predicate are identical |
| Anatomical Site | Wrist | Wrist | The subject device and the predicate are identical |
| Over the Counter or Rx | Rx | Rx | The subject device and the predicate are identical |
| Environment | Home | Home | The subject device and the predicates are identical. |
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| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Alarms | No | No | The subject device and the predicates are identical. |
| User Interface | Device LED. | Device screen, Mobile device application, and cloud software platform | The subject device has only an LED. The subject device and predicate device share the same mobile application and cloud software platform. |
| Energy Source | Battery | Battery | The subject device and the predicates are identical |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | The subject device and the predicates are identical |
| Wireless Communication Interface | Bluetooth® Low Energy (device to mobile device) | Bluetooth® Low Energy (device to mobile device)IEEE 802.11 WiFi/cellular to Empatica cloud | The subject device and the predicate are identical |
| Patient contacting materials | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | The subject device and the predicate are identical |
Technical and Performance Information for Activity and Sleep
| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Technology | Accelerometer | Accelerometer | The subject device and the predicate are identical |
| Accelerometer Type | Microelectromechanical system (MEMS)-based integrated circuit | Microelectromechanical system (MEMS)-based integrated circuit | The subject device and the predicate are identical |
| Accelerometer Sampling Rate | Digital method, 26 Hz – 208 Hz | Digital method, 26 Hz – 208 Hz | The subject device and the predicate are identical |
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Technical and Performance Information for Activity and Sleep
| Features | EmbraceMini (Subject Device) | Empatica Health Monitoring Platform (K230457) | Analysis of differences |
|---|---|---|---|
| Accelerometer Dynamic Range | ± 16 g | ± 16 g | The subject device and the predicate are identical |
| Accelerometer Sensitivity | 0.488 milli-g per Least Significant Bit | 0.488 milli-g per Least Significant Bit | The subject device and the predicate are identical |
The EmbraceMini presented in this 510(k) submission has introduced no changes to the computation of ActivityCounts and activity during sleep (ACT and SLEEP) compared with the predicate device. Validation testing has been performed to ensure equivalence between EmbraceMini and the predicate.
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VIII. PERFORMANCE DATA
Non-Clinical testing (Bench testing)
The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:
| Test Name | Test Description | Results |
|---|---|---|
| Biocompatibility testing | EmbraceMini was tested 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" September 8, 2023, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests:• Cytotoxicity• Sensitization• IrritationEmbraceMini is considered skin surface contacting for a permanent duration (> 30 days). | Passed |
| Electrical safety testing | EmbraceMini was tested in accordance with International Standard IEC 60601-1 for electrical safety. | Passed |
| Electromagnetic compatibility (EMC) testing | EmbraceMini was tested in accordance with International Standard IEC 60601-1-2 for EMC. | Passed |
| Wireless Radio Communication | EmbraceMini was tested to ensure it can communicate via wireless radio in its intended environment in compliance with FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013. | Passed |
| Usability testing | EmbraceMini has been assessed with regards to usability for compliance with IEC 62366-1. EmbraceMini was also tested in accordance with International Standard IEC 60601-1-6 for Usability of medical devices. | Passed |
| Home-Use testing | EmbraceMini was tested in accordance with International Standard IEC 60601-1-11 for medical devices used in home healthcare environments. | Passed |
| Activity Counts/Sleep | Bench testing has been performed to demonstrate the equivalence of EmbraceMini activity counts and sleep detection with the predicate device. | Passed |
Software Verification and Validation Testing
Software verification and validation testing have been successfully conducted. Software documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions" for Basic documentation level.
Cybersecurity
Cybersecurity activities have been conducted and an assessment made on individual component risks. Documentation has been provided with this application as recommended by the FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". EmbraceMini software components underwent appropriate cybersecurity assessment and testing.
Animal study
No animal studies have been conducted as part of this submission to prove substantial equivalence, as the device is not intended for contact with compromised skin.
Clinical Study
No clinical studies have been performed on the subject device as part of this submission to prove substantial equivalence
IX. CONCLUSION
Based on the information presented in this 510(k) premarket notifications, EmbraceMini is substantially equivalent to the predicate devices. EmbraceMini is as safe and effective as the currently marketed predicate device.
Based on testing and comparison with the predicate device, EmbraceMini indicated no adverse indications or results. It is our determination that EmbraceMini is safe, effective and performs within its design specifications, and is substantially equivalent to the predicate device.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.