Withings Sleep Rx
Device Facts
| Record ID | K231667 |
|---|---|
| Device Name | Withings Sleep Rx |
| Applicant | Withings |
| Product Code | MNR · Anesthesiology |
| Decision Date | Sep 6, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Obstructive Sleep Apnea (OSA) screening | Embedded software algorithms analyzing sound and pressure signals. | 95% confidence interval lower bound > 0.70 | Sensitivity: 0.88 (AHI ≥ 15), 0.86 (AHI ≥ 30); Specificity: 0.886 (AHI ≥ 15), 0.912 (AHI ≥ 30); AUC: 0.926 (AHI ≥ 15), 0.954 (AHI ≥ 30) | ESAS study (training data for Withings index). | — | NCT04234828 (Clinical validation study): 118 patients with suspected OSAS. | >1 (certified specialists) |
| Heart rate | Embedded software algorithms analyzing pressure signals. | Lower bound 95% confidence interval > 0.95 | Accuracy: 0.9597 (Lower bound 95% CI: 0.9523) | ESAS study (training data for Withings index). | — | Pooled post-hoc analysis of ESAS and VPASS studies. | >1 (qualified investigators) |
| Movement detection | Embedded software algorithms analyzing pressure signals. | AUC > 0.80 | Active/non-active Se: 0.92, Sp: 0.92; Full body/legs AUC: 0.94; Legs/arms AUC: 0.93; Arms/no movement AUC: 0.89 | — | — | Internal human study simulating sleep movements. | — |
Indications for Use
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations.
Device Story
Contactless under-mattress device; uses pneumatic bladder pressure sensor and audio microphone to capture respiration, heart rate, and movement signals. Embedded microcontroller processes signals to calculate Withings index (breathing events per hour), heart rate, and movement. Data transmitted via Bluetooth/Wi-Fi to companion mobile app for clinician/patient review. Assists healthcare professionals in determining need for further sleep apnea evaluation. Not a substitute for full polysomnography; no real-time alarms.
Clinical Evidence
Clinical validation (NCT04234828) in 118 patients compared device to PSG. For AHI ≥ 15: sensitivity 0.88, specificity 0.886, AUC 0.926. For AHI ≥ 30: sensitivity 0.86, specificity 0.912, AUC 0.954. Heart rate estimation accuracy 0.9597 (lower bound 95% CI 0.9523). Internal movement detection study showed AUCs 0.89–0.94 for various movement classifications. All metrics met pre-defined acceptance criteria.
Technological Characteristics
Components: Mat (thermoplastic polyurethane bladder, polyester fabric), embedded software, companion app. Sensing: Pneumatic pressure sensor and audio microphone. Connectivity: Bluetooth Low Energy, Wi-Fi. Power: 5V. Dimensions: 637 x 195 x 24 mm. Software: Embedded microcontroller algorithms for signal processing, filtering, and parameter estimation.
Indications for Use
Indicated for adults ≤ 350 lbs with suspected sleep breathing disorders for home-screening and as an aid in diagnosing obstructive sleep apnea (OSA). Not for active patient monitoring or life-threatening situations.
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Predicate Devices
- Drowzle (K173974)
Reference Devices
- EarlySense Insight System (K152911)
Submission Summary (Full Text)
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September 6, 2024
Withings Khushboo Surendran Regulatory Affairs Manager 2 Rue Maurice Hartmann Issy-Les-Moulineaux, Ile-De-France 92130 France
# Re: K231667
Trade/Device Name: Withings Sleep Rx Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: August 5, 2024 Received: August 5, 2024
Dear Khushboo Surendran:
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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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 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-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 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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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).
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Sincerely,
Digitally signed by Binoy J. Mathews -S Binoy J. Mathews -S Date: 2024.09.06 14:09:37 -04'00'
For
Rachana Visaria Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K231667
Device Name Withings Sleep Rx
#### Indications for Use (Describe)
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).
The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.
The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in lifethreatening situations.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary
# 1. Submitter
| Applicant: | Withings<br>2 Rue Maurice Hartmann<br>Issy-Les-Moulineaux<br>France 92130 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Submission<br>Correspondent: | Khushboo Surendran<br>Regulatory Affairs Manager<br>Phone: 857-233-2681<br>Email: khushboo.surendran@withings.com |
| Back-Up Consulting<br>Correspondent: | Michael Daniel<br>Daniel & Daniel Consulting, LLC<br>Email: madaniel@clinregconsult.com |
Date Prepared: September 5th, 2024
# 2. Subject device Information
| Device Name: | Withings Sleep Rx |
|----------------------|-----------------------------|
| Regulation name: | Breathing frequency monitor |
| Regulation number: | 21 CFR 868.2375 |
| | |
| Regulatory Class: | Class II |
| Product Code: | MNR |
| 510(k) review panel: | Anesthesiology |
# 3. Predicates Information
| Predicate<br>Manufacturer: | Resonea, Inc |
|------------------------------------|---------------------------|
| Predicate device name: | Drowzle |
| Predicate 510(k)<br>number: | K173974 |
| Reference device<br>Manufacturer: | EarlySense Ltd. |
| Reference device<br>name: | EarlySense Insight System |
| Reference device<br>510(k) number: | K152911 |
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### 4. Description of the device
The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation.
In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app.
Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.
### 5. Indications for Use
Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA).
The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner.
The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.
The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations.
# 6. Comparison table with subject device, predicate and reference device
The following table presents a high-level comparison between the subject device (Withings Sleep Rx), the predicate device (Drowzle) and the reference device (EarlySense Bed Sensing Unit) for the indications for use, technological characteristics, and principle of operation.
| Description | Subject device<br>Withings Sleep Rx<br>(K231667) | Predicate device<br>Drowzle<br>(K173974) | Reference device<br>EarlySense Bed<br>Sensing Unit<br>(K152911) | Comparison<br>(Similarities/<br>Differences) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Withings Sleep Rx | Drowzle | EarlySense Insight<br>System | N.A. |
| Manufacturer | Withings | Resonea, Inc | EarlySense Ltd | N/A |
| Regulation number | 868.2375 | 868.2375 | 868.2375 | Identical |
| Description | Subject device<br>Withings Sleep Rx<br>(K231667) | Predicate device<br>Drowzle<br>(K173974) | Reference device<br>EarlySense Bed<br>Sensing Unit<br>(K152911) | Comparison<br>(Similarities/<br>Differences) |
| Class | II | II | II | Identical |
| Product code | MNR | MNR | BZQ | Identical to predicate |
| 510(k) Review panel | Anesthesiology | Anesthesiology | Anesthesiology | Identical |
| Prescription / OTC | Prescription | Prescription | Prescription | Identical |
| Intended population | Adults | Adults | Adults, adolescents, and children | Identical to predicate. |
| Intended<br>environment for use | Home environment | Home environment | Home and Clinical<br>environment | Identical to predicate. |
| Intended Use | Home-use device for<br>aiding to diagnosis<br>patients with possible<br>sleep disorders. | Home-use device for<br>screening patients with<br>possible sleep<br>disorders. | Intended for continuous<br>measurement of<br>respiration rate, heart<br>rate and movement, in<br>an automatic contact-<br>less manner. | Identical to predicate |
| Indications for use | Withings Sleep Rx is<br>indicated to record a<br>patient's Withings<br>index during sleep as<br>an aid for diagnosis of<br>obstructive sleep<br>apnea (OSA).<br>The Withings Sleep Rx<br>is also indicated to<br>record heart rate and<br>movement in an<br>automatic contactless<br>manner.<br>The device is designed<br>for use in home-<br>screening of adults<br>with suspected<br>possible sleep<br>breathing disorders.<br>Results are used to<br>assist the healthcare<br>professional in<br>determining the need<br>for further diagnosis<br>and evaluation. The<br>system is not intended<br>as a substitute for full<br>polysomnography<br>when additional<br>parameters such as<br>sleep stages, limb | Drowzle is indicated to<br>record a patient's<br>respiratory pattern<br>during sleep for the<br>purpose of pre-<br>screening patients for<br>obstructive sleep<br>apnea (OSA)<br>syndrome.<br>The device is designed<br>for use in home-<br>screening of adults<br>with suspected<br>possible sleep<br>breathing disorders.<br>Results are used to<br>assist the healthcare<br>professional in<br>determining the need<br>for further diagnosis<br>and evaluation. The<br>system is not intended<br>as a substitute for full<br>polysomnography | The EarlySense Bed<br>Sensing Unit is an<br>accessory that is<br>compatible with<br>bedside units of<br>EarlySense Systems<br>(Models 2.0 and<br>InSight) intended for<br>continuous<br>measurement of<br>respiration rate, heart<br>rate and movement,<br>in an automatic<br>contact-less manner.<br>Environment of use for<br>the accessory is<br>defined as per<br>compatible cleared<br>bedside units labeling:<br>EarlySense 2.0 - at<br>home, in hospital or<br>clinic setting and<br>InSight - in hospital or<br>clinic setting.<br>The device is indicated<br>for use in children,<br>adolescents and<br>adults. | Identical to predicate.<br>In addition, the<br>indication for<br>movement detection<br>and heart rate<br>estimation in a contact-<br>less manner is<br>identical to the<br>reference device. |
| Description | Subject device<br>Withings Sleep Rx<br>(K231667) | Predicate device<br>Drowzle<br>(K173974) | Reference device<br>EarlySense Bed<br>Sensing Unit<br>(K152911) | Comparison<br>(Similarities/<br>Differences) |
| | movements, or EEG<br>activity are required.<br>The device is indicated<br>for use in adults<br>weighing ≤ 350 lbs in a<br>home environment<br>during sleep and<br>resting conditions.<br>This device is not<br>indicated for active<br>patient monitoring, as<br>it does not provide<br>alarms for timely<br>response in life-<br>threatening situations. | when additional<br>parameters such as<br>sleep stages, limb<br>movements, or EEG<br>activity are required. | The operation of the<br>EarlySense system<br>has been studied in<br>children (weight ≥10<br>Kg) and adults (weight<br><111 Kg) during sleep<br>and resting condition. | |
| Device placement<br>and patient contact | The Withings Sleep Rx<br>is placed under the<br>bed mattress - not<br>touching the patient | Smartphone placed<br>within 24 inches of<br>pillow | The Bed Sensing Unit<br>is placed under the<br>bed mattress - not<br>touching the patient | Identical. All the<br>devices are<br>contactless. |
| Sensor Technology | A pneumatic bladder<br>with a pressure sensor<br>is used to detect<br>motion signals<br>(mechanical<br>movements) in a<br>contact-less manner.<br>These signals are<br>converted into an<br>electrical signal,<br>sampled, filtered and<br>transferred to the<br>embedded<br>microcontroller where<br>they are analyzed by<br>the device's software<br>(algorithms) to provide<br>the Withings index,<br>heart rate (HR), and<br>movement. Bed exit<br>signal is also detected<br>and available. The<br>signal of the pneumatic<br>sensor is also<br>decomposed into a<br>breathing component<br>by the algorithm (not<br>shown to the patient). | N/A | Piezoelectric ceramic<br>sensing element is<br>used to detect motion<br>signals (mechanical<br>movements) in a<br>contact-less manner.<br>These signals are<br>converted into an<br>electric signal,<br>sampled, filtered and<br>transferred to the<br>Bedside Unit where<br>they are analyzed by<br>the Bedside unit's<br>software (algorithms)<br>to provide the<br>respiration rate (RR),<br>heart rate (HR), and<br>motion. Bed exit signal<br>is also detected and<br>available. | Similar to the reference<br>device. Both devices<br>detect<br>motion signals<br>(mechanical<br>movements) in a<br>contact less-manner.<br>Both devices<br>estimate the same<br>parameters:<br>heart rate (HR),<br>movement and bed<br>exit detection except<br>for respiratory rate. |
| | Device also includes<br>an audio sensor | Microphone(s) native<br>to smartphone placed | N/A | Similar to the predicate<br>device. Both devices |
| Description | Subject device<br>Withings Sleep Rx<br>(K231667) | Predicate device<br>Drowzle<br>(K173974) | Reference device<br>EarlySense Bed<br>Sensing Unit<br>(K152911) | Comparison<br>(Similarities/<br>Differences) |
| | (microphone) that<br>analyzes sound to<br>identify breathing<br>sound and estimates<br>gaps in breathing<br>sounds. | within 24 inches of<br>pillow analyzes sound<br>to identify breathing<br>sound and estimates<br>gaps in breathing<br>sounds. | | are placed close to the<br>user in a contactless<br>manner to record<br>breathing sounds. The<br>subject device<br>combines the<br>breathing sounds with<br>pressure changes<br>measured by the<br>pressure sensor<br>to estimate respiratory<br>events indicative of<br>sleep apnea whereas<br>the predicate device<br>uses only the<br>breathing sounds to<br>estimate respiratory<br>events indicative of<br>sleep apnea. |
| Material used | Inner bladder:<br>thermoplastic<br>polyurethane<br>Outer Protective fabric:<br>Polyester | N/A | ABS/Polycarbonate<br>plate | Different. This<br>difference does not<br>affect safety due to the<br>contactless nature of<br>the device. |
| Signals acquired | Sounds from<br>respiration.<br>Pressure changes due<br>to body motion, chest<br>movement<br>(respiration), and<br>vibrations created by<br>the heart. | Sounds from<br>respiration. | Piezoelectric signal<br>generated by<br>variations of pressure<br>applied on the device<br>due to body motion,<br>chest movement<br>(respiration), and<br>vibrations created by<br>the heart. | Similar to predicate<br>and reference device |
| Algorithm processing | Analyzes sound and<br>pressure signals to<br>identify respiratory<br>events indicative of<br>sleep apnea or other<br>disorders.<br>Analyzes the pressure<br>signal to calculate<br>heart rate and detect<br>movements. | Analyzes the sound<br>signal to identify<br>respiratory events<br>indicative of sleep<br>apnea or other<br>disorders | Analyzes the<br>piezoelectric signal to<br>calculate heart rate<br>and respiration rate,<br>and to detect<br>movements. | The subject device<br>analyzes the measured<br>signals similarly to the<br>predicate and<br>reference device. |
| Algorithm outputs<br>displayed to the user | Withings index<br>(estimated frequency<br>of breathing events<br>during sleep). | Resonea index<br>(frequency of breathing<br>events during sleep) | N/A | Similar to the predicate<br>device |
| Description | Subject device<br>Withings Sleep Rx<br>(K231667) | Predicate device<br>Drowzle<br>(K173974) | Reference device<br>EarlySense Bed<br>Sensing Unit<br>(K152911) | Comparison<br>(Similarities/<br>Differences) |
| | - Heart Rate<br>- Movement | N/A | - Heart Rate,<br>- Motion<br>- Respiration Rate<br>- Bed occupancy<br>data<br>- Alerts | The subject and<br>reference devices<br>display heart rate and<br>movement during the<br>night. The subject<br>device does not<br>display respiration rate<br>nor provides alerts. |
| Definition of<br>breathing events | Estimated amount of<br>breathing sound gaps<br>>10 seconds<br>Average number of<br>>10 second breathing<br>sound gaps per hour | Estimated amount of<br>breathing sound gaps<br>>10 seconds<br>Average number of<br>>10 second breathing<br>sound gaps per hour | N/A | Identical to the<br>predicate device |
| Heart rate range and<br>accuracy | Range: 37 - 110 beats<br>per minute<br>Accuracy as<br>compared to ECG<br>heart rate: ±5 BPM | N/A | Range: 30 - 170 beats<br>per minute<br>Accuracy as<br>compared to ECG<br>heart rate: ±4% or ±5<br>BPM, whichever is<br>greater | The range is different.<br>The subject device<br>labeling warns that the<br>subject device is not<br>intended f…
