XBody Go USA, XBody Pro USA

K221200 · Xbody Hungary Kft. · NGX · Jan 31, 2023 · Physical Medicine

Device Facts

• Record ID: K221200
• Device Name: XBody Go USA, XBody Pro USA
• Applicant: Xbody Hungary Kft.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.

Device Story

XBody Go USA and XBody Pro USA are powered muscle stimulators using EMS technology to trigger action potentials on motor nerves, inducing mechanical muscle fiber response. Input consists of user-selected training parameters (pulse frequency, duration, session length) via a touchscreen tablet (Microsoft Surface). The system includes a wireless stimulation unit (XBody Actiwear G2) and a training suit with integrated electrodes. Used in home or clinic settings by certified trainers to manage muscle training programs. Output is electrical stimulation delivered to muscle groups. The device provides performance data (session duration, client data) to the trainer. Benefits include improved muscle performance through customized training. Safety features include overload/no-load trip, watchdog monitoring, and emergency stop buttons. The device is not for medical treatment or rehabilitation.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance supported by independent testing to international standards including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (nerve/muscle stimulators), and IEC 62304 (software). Usability testing confirmed the interface and Go Out mode safety. Biocompatibility of applied parts (underwear/electrodes) confirmed per ISO 10993.

Technological Characteristics

Powered muscle stimulator; symmetric biphasic waveform; 1-150Hz frequency; 50-500usec pulse width. Materials: Plastic housing, textile training suit (polyamide, polyester, acrylic, elastane). Connectivity: Wi-Fi/Bluetooth. Power: Li-ion rechargeable battery. Software: IEC 62304 compliant. Safety: Overload/no-load trip, watchdog monitoring. Sterilization: Washable/disinfectable electrodes.

Indications for Use

Indicated for healthy individuals to stimulate muscles to improve or facilitate muscle performance as an addition to sports and training. Contraindicated for use on injured or ailing muscles and for rehabilitation purposes.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• XBody Newave USA (K190038)

Reference Devices

• WiemsPro (K181955)

Submission Summary (Full Text)

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January 31, 2023

XBody Hungary Kft. % Bhoomika Joyappa Associate Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd Shrewsbury, Vermont 05738

Re: K221200

Trade/Device Name: XBody Go USA, XBody Pro USA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: January 17, 2023 Received: January 17, 2023

Dear Bhoomika Joyappa:

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.

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Tushar Bansal -S

for Heather Dean, PhD

Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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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# Indications for Use

510(k) Number (if known) K221200

Device Name XBODY Go USA and XBODY Pro USA

#### Indications for Use (Describe)

The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Premarket Notification [510(k) Summary] K221200

# A. General Information

Regulation Number:

| Sponsor's Name: | XBody Hungary Kft. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor's Contact Person: | Orsolya Balog (Regulatory Compliance) |
| Address: | György Aladár u. 35-39 Budapest, Hungary 1125<br>[e-mail]<br>www.XBodyworld.com |
| Phone | [phone] |
| Submission Contact Person: | Bhoomika Joyappa |
| Address: | Associate Regulatory Consultant<br>Medical Device Academy, Inc<br>[e-mail]<br>345 Lincoln Hill Rd,<br>Shrewsbury, VT 05738 |
| Phone | +1.201-290-2613 |
| Date Prepared: | April 4, 2022 |
| B. Device | |
| Trade Names of Companion Products: | XBody Go USA, XBody Pro USA |
| Common Name: | Powered Muscle Stimulator |
| Product Classification Code: | NGX |
| Regulatory Class: | 2 |
| Device Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulation Name: | Powered Muscle Stimulator |

21 CFR 890.5850

1

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| Primary Predicate Device: | XBody Newave USA |
|---------------------------|----------------------|
| Manufacturer: | XBody Hungary Kft |
| Predicate 510(k) Number: | K190038 |
| Reference Device: | WiemsPro |
| Manufacturer: | Medical Cables, S.L. |
| Reference 510(K) Number: | K181955 |

# C. Identification of Legally Marketed Primary Predicate Device and Reference Device

## D. Description of the Devices

The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on EMS technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.

## E. Indication for Use

The XBody Go USA and XBody Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used for only healthy not for rehabilitation purposes.

Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the XBody Go USA or XBody Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.

For both models, electrical impulses allow the triggering of action potentials on motor nerves (excitations). These excitations of motoneurons are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBody Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. Both models may therefore be considered a technique of muscle training.

## F. Technological Characteristics

Compared to the primary predicate device, the XBody Pro USA are the same or similar in indication for use, intended use performance, design, dimensions, and materials as the primary predicate and reference devices meet the same standards for safety and performance as the primary predicate and reference devices.

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The differences cited in the comparison tables between subject, primary predicate and reference devices do not affect safety and performance of the subject devices when compared for equivalence to the primary predicate and reference devices. Where is not publicly available information for a comparison between the two subject devices (XBody Go USA) and on of the predicates (WiemsPro) in Table 1 and 3, this application relies on the subject devices to XBody Newave USA. This is noted where appropriate as "No information publicly available."

Comment on WiemsPro. This reference device is used for its wireless attributes for comparison to XBody subject devices.

| Table 1 | | | | | |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------|
| Comparison of Subject Devices (XBody Go USA and XBody Pro USA) to Predicate and Reference Devices: | | | | | |
| General and Electrical Parameters | | | | | |
| Parameter /<br>application | Subject Device<br>XBody Go USA<br>and<br>XBody Pro USA<br>(K221200) | Primary Predicate<br>XBODY Newave USA<br>(K190038) | Reference Device<br>WiemsPro<br>(K181955) | Assessment of Substantial Equivalence | |
| | | | | XB Go USA & XB Pro USA vs.<br>XB Newave USA | XB Go USA & XB Pro USA<br>vs. WiemsPro |
| | | | | | |
| Powered Muscle<br>Stimulator | Yes | Yes | Yes | Same | Same |
| Regulated voltage | Yes | Yes | Yes | Same | Same |
| Intended use | The XBody Go<br>USA and XBody<br>Pro USA are<br>machines with<br>electronic muscle<br>stimulation based on<br>EMS technology.<br>The devices are<br>specifically designed<br>as an addition to<br>other sports and for<br>training muscles.<br>They must be used<br>for only healthy<br>muscles and people | The XBody Newave USA<br>is a machine with<br>electronic muscle<br>stimulation based on EMS<br>technology. The device is<br>specifically designed as an<br>addition to other sports<br>and for training muscles.<br>It must be used for only<br>healthy muscles and<br>people (clients), not for<br>rehabilitation purposes. | WiemsPro is intended to<br>stimulate healthy muscles<br>in order to<br>improve or facilitate<br>muscle performance. The<br>WiemsPro is not intended<br>to be used in conjunction<br>with therapy or treatment<br>of medical diseases or<br>medical conditions of any<br>kind. None of WiemsPro<br>training programs is<br>designed for injured or<br>ailing muscles and its use<br>on such muscles | Same | Same |

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| (clients), not for<br>rehabilitation<br>purposes. | stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance The XBody<br>Newave USA is not<br>intended to be used in<br>conjunction with therapy<br>or treatment of medical<br>diseases or medical<br>conditions of any kind.<br>None of the XBody<br>Newave USA training<br>programs is designed for<br>injured or ailing muscles<br>and its use on such<br>muscles is<br>contraindicated.<br>The XBody electrical<br>impulses allow the<br>triggering of action<br>potentials on motoneurons<br>of motor nerves<br>(excitations). These<br>excitations of motoneurons<br>are transmitted to the<br>muscle fibers via the<br>motor endplate where they<br>generate mechanical<br>muscle fiber responses that<br>correspond to muscle<br>work. Depending on the<br>parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration), different | is contraindicated.<br><br>WiemsPro is a machine<br>with electronic muscle<br>stimulation based on EMS<br>technology.<br>Regarding its use, the<br>device is specifically<br>designed as an addition to<br>other sports and for<br>training muscles. It must<br>be used for only healthy<br>muscles and clients, not<br>for rehabilitation<br>purposes.<br><br>WiemsPro electrical<br>impulses allow the<br>triggering of action<br>potentials on<br>motoneurones of motor<br>nerves (excitations).<br>These excitations of<br>motoneurones are<br>transmitted to the muscle<br>fibers via the motor<br>endplate where they<br>generate mechanical<br>muscle fiber responses<br>that correspond to<br>muscle work. Depending<br>on the parameters of the<br>electrical impulses<br>(pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration), | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|--|--|--|
| motoneurons are<br>transmitted to the<br>muscle fibers via the<br>motor endplate<br>where they generate<br>mechanical muscle<br>fiber responses that<br>correspond to<br>muscle work.<br>Depending on the<br>parameters of the<br>electrical impulses<br>(pulse frequency,<br>duration of<br>contraction,<br>duration of rest,<br>total session<br>duration), different<br>types of muscle<br>work can be<br>imposed on the<br>stimulated muscles.<br><br>The various types<br>of muscle work that<br>the XBody Go<br>USA or XBody Pro<br>USA can impose on<br>the stimulated<br>muscles are able to<br>improve or<br>facilitate muscle<br>performance. The<br>XBody Go USA<br>and the XBody Pro<br>USA may therefore<br>be considered as a | be imposed on the<br>stimulated muscles.<br><br>The various types of<br>muscle work that the<br>XBody Newave USA can<br>impose on the stimulated<br>muscles are able to<br>improve or facilitate<br>muscle performance. The<br>XBody Newave USA<br>may therefore be<br>considered a technique of<br>muscle training. | work<br>can be imposed on the<br>stimulated muscles. | | | muscle training. | | | | |
| Portability/ Mobile<br>Use | The device is<br>portable with ease.<br>It is not a mobile<br>device; its intended<br>environment is<br>indoors. Its intended<br>use requires a<br>qualified and trained<br>operator. | The device is portable (17<br>lbs.), but it is not a mobile<br>device. Its intended use<br>requires the presence of a<br>qualified and trained<br>operator. | No information publicly<br>available | Similar. Both the primary<br>predicate device and the subject<br>devices are portable. | N/A | | | | |
| Go out Mode | Present | Not available | No information publicly<br>available | This is an additional upgrade to the<br>device's functionality. The impact<br>of the Go out mode on safety and<br>effectiveness was evaluated<br>through risk management. In Go<br>out mode, you have a lot of<br>freedom and flexibility to<br>customize your training, so it is an<br>exceptionally useful feature. With<br>the issued risk control measures,<br>safety of the Go out mode is<br>ensured. Users are provided with<br>comprehensive information in user<br>manuals for the device before<br>using it during training, reducing<br>the risk of accidents | N/A | | | | |
| User interface | The device can be<br>controlled using the<br>graphical windows<br>appearing on the<br>touchscreen of the<br>external control unit<br>(Microsoft Surface | The device can be<br>controlled using the<br>graphical windows<br>appearing on the<br>touchscreen of the device.<br>On the training screen<br>where stimulation | No information publicly<br>available | Similar. Both the primary<br>predicate device and the subject<br>devices utilize a device with<br>touchscreen as control unit. | N/A | | | | |

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| Go 2 for XBody Go<br>USA / Microsoft<br>Surface Pro 7+ for<br>XBody Pro USA).<br>On the training<br>screen where<br>stimulation controls<br>can be used the<br>START/ STOP<br>buttons are large and<br>easily controllable.<br>Stimulation controls<br>for adjusting<br>channel intensities,<br>and all other<br>stimulation<br>parameters are<br>clearly visible and<br>easily controllable.<br>Channel<br>identification is<br>supported with big<br>pictures showing the<br>selected muscle<br>groups. When the<br>stimulation is on,<br>the STOP button is<br>always visible and<br>accessible. | controls can be used the<br>START/ STOP buttons<br>are large and easily<br>controllable. Stimulation<br>controls for adjusting<br>channel intensities, and<br>all other stimulation<br>parameters are clearly<br>visible and easily<br>controllable. Channel<br>identification is supported<br>with big pictures showing<br>the selected muscle<br>groups. When the<br>stimulation is on, the<br>STOP button is always<br>visible and accessible. | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Menu / Settings | Easy-to-use multi-<br>choice menu for<br>registered and<br>certified trainers to<br>customize training<br>parameters and<br>stimulation<br>Programs | Easy-to-use multi-choice<br>menu for registered and<br>certified trainers to<br>customize training<br>parameters and<br>stimulationPrograms. | No information publicly<br>available | Same | N/A | |
| Operator | To operate the | To operate the device the | No information publicly | Same | N/A | |
| | devices the trainer<br>must complete an<br>XBody US EMS | trainer must complete an<br>XBody US EMS Trainer<br>Course. The certification | available | | | |
| | Trainer Course. The<br>certification data | data received at the end of<br>the course is required | | | | |
| | received at the end<br>of the course is | when XBody registers<br>trainers in the device | | | | |
| | required when<br>XBody registers | database. Only registered<br>trainers can start training | | | | |
| | trainers in the device<br>database. Only | stimulation Programs<br>using a passcode. | | | | |
| | registered trainers<br>can start training | | | | | |
| | stimulation<br>Programs using a | | | | | |
| | passcode. | | | | | |
| Display | GO: <10.5" LCD<br>display on the<br>XBody Go USA<br>tablet><br>PRO: <12.3" LCD<br>display on the<br>XBody Pro USA<br>tablet > | 10.4" resistive<br>touchscreen | No information publicly<br>available | Different. Subject devices have<br>bigger screens with capacitive<br>LCD touch screens providing<br>more accurate touch reading | Similar | |
| Statistical<br>Functions | Training data<br>(trainer, client,date,<br>duration). Client<br>related data.<br>Number of training<br>sessions (today, | Training data (trainer,<br>client,date, duration).<br>Client related data.<br>Number of training<br>sessions (today,yesterday,<br>this week, this month,<br>total). | No information publicly<br>available | Same | N/A | |
| | yesterday, this week,<br>this month, total). | | | | | |
| Output<br>specifications | Max Output Voltage | Max Output Voltage =<br>20.8V @500 $\Omega$ | Max Output Voltage =<br>30V @500 $\Omega$ | Max Output Voltage<br>= 62.5V @500 $\Omega$ | Similar. Subject devices have<br>lower max output voltage.<br>This particular feature has<br>already been tested to IEC | Different. Subject devices have<br>lower max output voltage.<br>This particular feature has<br>already been tested to IEC |

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| Max Output Current | Max Output Current =60<br>mA @500Ω | Max Output Current<br>= 125mA @500Ω | 60601-1:2005+ A1:2012+<br>A2:2020. This difference does<br>not raise any concern for safety<br>and effectiveness.<br>Similar. Subject devices have<br>lower max output current. This<br>particular feature has already<br>been tested to IEC 60601-<br>1:2005+ A1:2012+ A2:2020.<br>This difference does not raise<br>any concern for safety and<br>effectiveness. | 60601-1:2005+ A1:2012+<br>A2:2020. This difference does<br>not raise any concern for safety<br>and effectiveness.<br>Different. Subject devices have<br>lower max output current. This<br>particular feature has already<br>been tested to IEC 60601-<br>1:2005+ A1:2012+ A2:2020.<br>This difference does not raise<br>any concern for safety and<br>effectiveness. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max Phase Charge<br>= 16.64μC@500Ω | Max Phase Charge<br>= 24μC@500Ω | No information publicly<br>available | Similar. Subject devices have<br>lower max phase charge. This<br>particular feature has already<br>been tested to IEC 60601-<br>1:2005+ A1:2012+ A2:2020.<br>This difference does not raise<br>any concern for safety and<br>effectiveness. | N/A | |
| Max Current<br>Density =<br>0.65mA/cm2<br>@500Ω | Max Current Density =<br>0.61mA/cm2 @500Ω | Max Current Density<br>=1.92mA/cm2 @500Ω | Similar. Subject devices have<br>lower max current density. This<br>particular feature has already<br>been tested to IEC 60601-<br>1:2005+ A1:2012+ A2:2020.<br>This difference does not raise<br>any concern for safety and<br>effectiveness.…