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 Description

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the XBody Go USA and XBody Pro USA, which are powered muscle stimulators. While it thoroughly compares the new devices to predicates and lists many standards and tests, it does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML medical device.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (XBody Newave USA and WiemsPro) through a comparison of various characteristics (technological, performance, safety standards, materials). For a device like a powered muscle stimulator, the "acceptance criteria" are generally tied to meeting recognized safety and performance standards (bench testing) and demonstrating similar intended use and technological characteristics to a legally marketed predicate, rather than a clinical effectiveness study with a specific metric like accuracy, sensitivity, or specificity for a diagnostic AI.

Therefore, many of the specific points requested regarding AI/ML device performance studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable or are not explicitly stated in this 510(k) document because the approval pathway relies on substantial equivalence to existing devices rather than a de novo clinical performance validation against a defined ground truth.

However, I can extract the relevant "acceptance criteria" which, in this context, are the various technical and safety parameters that need to be "similar" or "meet" established standards, and how these performances are demonstrated.

Here is the information that can be extracted or reasonably inferred from the provided text, addressing the prompt's points where applicable, and noting when the requested information is not present or not relevant to this type of device submission:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" in this context are the characteristics and performance parameters that are compared to the predicate devices to demonstrate substantial equivalence. The "reported device performance" is essentially the description of the subject device's characteristics and how they compare to the predicates.

Acceptance Criteria (Parameter)	Predicate Performance (XBody Newave USA, WiemsPro)	Reported Device Performance (XBody Go USA, XBody Pro USA)	Assessment / Conclusion of Substantial Equivalence
Intended Use	To stimulate healthy muscles to improve or facilitate muscle performance; not for rehabilitation or medical conditions.	Same. Designed as an addition to other sports and for training muscles; for healthy muscles/clients only.	Same.
Powered Muscle Stimulator	Yes	Yes	Same.
Regulated Voltage	Yes	Yes	Same.
Portability/Mobile Use	Portable (17 lbs.), not a mobile device; indoors, requires trained operator.	Portable with ease; not a mobile device; intended environment is indoors; requires qualified and trained operator.	Similar. Both are portable, not mobile.
User Interface	Device with touchscreen for control; large START/STOP buttons; clear stimulation controls and parameters; channel identification with pictures; STOP button always visible.	The device can be controlled using graphical windows on the touchscreen of an external control unit (Microsoft Surface Go 2 / Surface Pro 7+). Similar controls and visible STOP button.	Similar. Both utilize a touchscreen control unit. Supports usability performance testing.
Operator Requirements	Trainer must complete an XBody US EMS Trainer Course; certification data required for registration.	Trainer must complete an XBody US EMS Trainer Course; certification data required for registration; only registered trainers can use.	Same.
Display	10.4" resistive touchscreen	GO: <10.5" LCD; PRO: <12.3" LCD	Different/Similar. Subject devices have larger, capacitive LCD touchscreens. Considered similar as it supports usability.
Max Output Voltage	Predicate: 20.8V @500Ω; Reference: 30V @500Ω	62.5V @500Ω	Similar to Predicate (higher than predicate but tested to IEC 60601-1 for safety and effectiveness). Different compared to Reference. "This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+A2:2020. This difference does not raise any concern for safety and effectiveness."
Max Output Current	Predicate: 125mA @500Ω	60mA @500Ω	Similar (lower than predicate, tested to IEC 60601-1 for safety and effectiveness). "This difference does not raise any concern for safety and effectiveness."
Max Phase Charge	Predicate: 24µC@500Ω	16.64µC@500Ω	Similar (lower than predicate, tested to IEC 60601-1 for safety and effectiveness). "This difference does not raise any concern for safety and effectiveness."
Max Current Density	Predicate: 0.61mA/cm2 @500Ω; Reference: 1.92mA/cm2 @500Ω	0.65mA/cm2 @500Ω	Similar to Predicate (slightly higher but tested to IEC 60601-1 for safety and effectiveness). Different compared to Reference. "This difference does not raise any concern for safety and effectiveness."
Max Power Density	Predicate: 7.27mW/cm2 @500Ω; Reference: 9.61mW/cm2 @500Ω	3.46mW/cm2 @500Ω	Similar to Predicate (lower than predicate, tested to IEC 60601-1 for safety and effectiveness). Different compared to Reference. "This difference does not raise any concern for safety and effectiveness."
Waveform	Symmetric biphasic	Symmetric biphasic	Same.
Output Channels	10 individual, galvanically isolated channels for each output (Predicate); 1 output channel can shift in time to 10 outputs (Reference).	6 output channels, but 12 independently regulated outputs.	Similar to Predicate. Different compared to Reference (Subject devices have more independently regulated output channels).
Output Frequency	1-100Hz	1-150Hz	Different. "Object devices provide better customization through a wider spectrum of output frequency. During the summative evaluation, the users evaluated the feeling of stimulation positively. The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. Therefore, the difference would not affect safety and effectiveness of the subject device."
Pulse Width (Positive & Negative)	50-400µsec (Predicate); 100-400µsec (Reference)	50-500µsec	Different. "Object devices provide better customization through a wider spectrum of positive/negative pulse width. During the summative evaluation, the users evaluated the feeling of stimulation positively. The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+ A2:2020. Therefore, the difference would not affect safety and effectiveness of the subject device."
Power Source - Battery	12V 10Ah LiFePO4 battery in sealed housing (Predicate); LiPo 3.7V (2.4Ah) (Reference)	Li-ion 4x 3.7V (3.4Ah)	Similar. All use rechargeable batteries. Subject device chosen for light weight and compact design. Bench tested for function and safety (similar to WiemsPro).
Safety Circuits	Overload trip, No-load trip, battery voltage monitoring, hardware error detection at startup, watchdog monitoring (Predicate); Software/Firmware/Microprocessor Control, Automatic Overload Trip, Automatic Shut Off, Patient Override Control (Reference).	Overload trip, No-load trip, battery voltage monitoring, hardware error detection at startup, watchdog monitoring.	Same as Predicate. Different from Reference (subject devices utilize a wider range of safety features than reference).
Connectivity (Plugs/Wires)	Spiral cable connects control unit to training suit (Predicate).	Tablets and Actiwear G2 wireless stimulation unit are connected wirelessly. Actiwear G2 and Training Suit connected with magnetic connectors. Internal suit cable connects to snap fasteners to which detachable electrodes are attached via waterproof connections.	Different from Predicate. "Primary predicate has built-in control panel, while the subject device connects wirelessly with the control unit. The subject devices are worn by the client, therefore no spiral cable is needed to connect with the training suit." Wires are similar/compliant with safety requirements.
Conductivity	Client wears XBody cotton underwear; electrodes in cotton covers watered with tap water for conductivity.	Client wears XBody cotton underwear; electrodes in cotton covers watered with tap water for conductivity; washable/disinfectable.	Same.
Programs	4+10 (Predicate); 20 (Reference)	XBody Go USA: 5; XBody Pro USA: 6 (including manual settings and various training programs).	Same to Go USA vs. Predicate. Similar to Pro USA vs. Predicate. Different vs. Reference (XBody devices offer broader customization through manual programs).
Treatment Duration	1 min to 60 min maximum	1 min to 60 min maximum	Same.
Environment of Use	Home healthcare environment, according to IEC 60601-1-11.	Home healthcare environment, according to IEC 60601-1-11.	Same.
Compliance Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62366, IEC 62304.	All predicate standards, plus additional for wireless (ANSI/AAMI TIR 69:2017, IEEE/ANSI C63.27-2017, ANSI/AAMI TIR57:2016).	Same/Different. Subject device was tested to additional standards due to wireless capability, ensuring overall safety and effectiveness.
Training Suit	Predicate TS2.0: 75% Polyamide, 25% Polyester; 10 channels; 20 electrodes; 3kg.	TS2.1: Same material as TS2.0; 12 channels; 24 electrodes; 2.7-3.3kg. TS3.0: 40% Polyamide, 30% Acrylic, 25% Polyester, 5% Elastane; 12 channels; 24 electrodes; 1.8-2.4kg. Wider range of sizes and electrode shapes for both new suits.	Similar. Differences in material (TS3.0) and number of channels/electrodes for improved comfort/performance, without affecting safety or primary intended use. Performance testing supported similarity. Output specs for new suits are within similar ranges or lower than predicates.
Software	Not explicitly detailed beyond 'similar software platforms'.	Similar software platforms with some additional programming (e.g., UPBEAT, group training) for Pro USA. Validated to IEC 62304:2006+A1:2015.	Similar. Differences noted "do not affect the safety and effectiveness" and are for "user-friendly interface".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set (Performance Testing): The document states "summative evaluation, the users evaluated the feeling of stimulation positively" and "Performance testing of the Training Suit 3.0 demonstrated acceptable similarity". It also relies heavily on compliance with various IEC standards (bench testing). No specific sample size for a "test set" of patient data (as relevant for AI/ML diagnostic devices) is mentioned. The "test set" here refers to the device and its components undergoing engineering and electrical safety tests.
Data Provenance: Not applicable in the context of human data. The tests are bench tests and "summative evaluations" of "users" (likely trained operators or healthy volunteers) in a controlled environment as part of the engineering validation.
Retrospective/Prospective: Not applicable to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a powered muscle stimulator, not a diagnostic AI/ML device that requires expert-established ground truth from medical images or clinical outcomes. The "ground truth" for this device's safety and performance is established through compliance with recognized electrical safety, EMC, usability, and biocompatibility standards, and comparison to existing predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human interpretation or qualitative assessment of a test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device. The device itself delivers electrical stimulation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML diagnostic algorithm. The device's "performance" is its ability to safely and effectively deliver electrical stimulation according to its specifications, which is validated through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Implicit. For this type of device, the "ground truth" for demonstrating safety and efficacy is established by:
- Regulatory Standards: Compliance with international consensus standards like IEC 60601 series, ISO 14971, ISO 10993, etc.
- Predicate Device Performance: Demonstrating that the new device's technical characteristics and performance are substantially equivalent to a previously cleared device.
- Bench Testing: Engineering measurements conducted to verify specifications and safety.
- Usability Testing: Verification of safe and effective user interaction (mentioned as "usability performance testing" and "summative evaluation" where users "evaluated the feeling of stimulation positively").

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of AI/ML model development. Its development is based on engineering design, comparison to known safe and effective technologies, and adherence to established manufacturing and quality systems.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, the concept of "ground truth for the training set" is irrelevant in this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

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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 1125orsolya.balog@XBodyworld.com www.XBodyworld.com
Phone	+36308970191
Submission Contact Person:	Bhoomika Joyappa
Address:	Associate Regulatory ConsultantMedical Device Academy, Incbhoomika@fdaecopy.com345 Lincoln Hill Rd,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

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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

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 /application	Subject DeviceXBody Go USAandXBody Pro USA(K221200)	Primary PredicateXBODY Newave USA(K190038)	Reference DeviceWiemsPro(K181955)	Assessment of Substantial Equivalence
				XB Go USA & XB Pro USA vs.XB Newave USA	XB Go USA & XB Pro USAvs. WiemsPro

Powered MuscleStimulator	Yes	Yes	Yes	Same	Same
Regulated voltage	Yes	Yes	Yes	Same	Same
Intended use	The XBody GoUSA and XBodyPro USA aremachines withelectronic musclestimulation based onEMS technology.The devices arespecifically designedas an addition toother sports and fortraining muscles.They must be usedfor only healthymuscles and people	The XBody Newave USAis a machine withelectronic musclestimulation based on EMStechnology. The device isspecifically designed as anaddition to other sportsand for training muscles.It must be used for onlyhealthy muscles andpeople (clients), not forrehabilitation purposes.	WiemsPro is intended tostimulate healthy musclesin order toimprove or facilitatemuscle performance. TheWiemsPro is not intendedto be used in conjunctionwith therapy or treatmentof medical diseases ormedical conditions of anykind. None of WiemsProtraining programs isdesigned for injured orailing muscles and its useon such muscles	Same	Same

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(clients), not forrehabilitationpurposes.	stimulate healthy musclesin order to improve orfacilitate muscleperformance The XBodyNewave USA is notintended to be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.None of the XBodyNewave USA trainingprograms is designed forinjured or ailing musclesand its use on suchmuscles iscontraindicated.The XBody electricalimpulses allow thetriggering of actionpotentials on motoneuronsof motor nerves(excitations). Theseexcitations of motoneuronsare transmitted to themuscle fibers via themotor endplate where theygenerate mechanicalmuscle fiber responses thatcorrespond to musclework. Depending on theparameters of the electricalimpulses (pulse frequency,duration of contraction,duration of rest, totalsession duration), different	is contraindicated.WiemsPro is a machinewith electronic musclestimulation based on EMStechnology.Regarding its use, thedevice is specificallydesigned as an addition toother sports and fortraining muscles. It mustbe used for only healthymuscles and clients, notfor rehabilitationpurposes.WiemsPro electricalimpulses allow thetriggering of actionpotentials onmotoneurones of motornerves (excitations).These excitations ofmotoneurones aretransmitted to the musclefibers via the motorendplate where theygenerate mechanicalmuscle fiber responsesthat correspond tomuscle work. Dependingon the parameters of theelectrical impulses(pulse frequency,duration of contraction,duration of rest, totalsession duration),
motoneurons aretransmitted to themuscle fibers via themotor endplatewhere they generatemechanical musclefiber responses thatcorrespond tomuscle work.Depending on theparameters of theelectrical impulses(pulse frequency,duration ofcontraction,duration of rest,total sessionduration), differenttypes of musclework can beimposed on thestimulated muscles.The various typesof muscle work thatthe XBody GoUSA or XBody ProUSA can impose onthe stimulatedmuscles are able toimprove orfacilitate muscleperformance. TheXBody Go USAand the XBody ProUSA may thereforebe considered as a	be imposed on thestimulated muscles.The various types ofmuscle work that theXBody Newave USA canimpose on the stimulatedmuscles are able toimprove or facilitatemuscle performance. TheXBody Newave USAmay therefore beconsidered a technique ofmuscle training.	workcan be imposed on thestimulated muscles.			muscle training.
Portability/ MobileUse	The device isportable with ease.It is not a mobiledevice; its intendedenvironment isindoors. Its intendeduse requires aqualified and trainedoperator.	The device is portable (17lbs.), but it is not a mobiledevice. Its intended userequires the presence of aqualified and trainedoperator.	No information publiclyavailable	Similar. Both the primarypredicate device and the subjectdevices are portable.	N/A
Go out Mode	Present	Not available	No information publiclyavailable	This is an additional upgrade to thedevice's functionality. The impactof the Go out mode on safety andeffectiveness was evaluatedthrough risk management. In Goout mode, you have a lot offreedom and flexibility tocustomize your training, so it is anexceptionally useful feature. Withthe issued risk control measures,safety of the Go out mode isensured. Users are provided withcomprehensive information in usermanuals for the device beforeusing it during training, reducingthe risk of accidents	N/A
User interface	The device can becontrolled using thegraphical windowsappearing on thetouchscreen of theexternal control unit(Microsoft Surface	The device can becontrolled using thegraphical windowsappearing on thetouchscreen of the device.On the training screenwhere stimulation	No information publiclyavailable	Similar. Both the primarypredicate device and the subjectdevices utilize a device withtouchscreen as control unit.	N/A

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Go 2 for XBody GoUSA / MicrosoftSurface Pro 7+ forXBody Pro USA).On the trainingscreen wherestimulation controlscan be used theSTART/ STOPbuttons are large andeasily controllable.Stimulation controlsfor adjustingchannel intensities,and all otherstimulationparameters areclearly visible andeasily controllable.Channelidentification issupported with bigpictures showing theselected musclegroups. When thestimulation is on,the STOP button isalways visible andaccessible.	controls can be used theSTART/ STOP buttonsare large and easilycontrollable. Stimulationcontrols for adjustingchannel intensities, andall other stimulationparameters are clearlyvisible and easilycontrollable. Channelidentification is supportedwith big pictures showingthe selected musclegroups. When thestimulation is on, theSTOP button is alwaysvisible and accessible.
Menu / Settings	Easy-to-use multi-choice menu forregistered andcertified trainers tocustomize trainingparameters andstimulationPrograms	Easy-to-use multi-choicemenu for registered andcertified trainers tocustomize trainingparameters andstimulationPrograms.	No information publiclyavailable	Same	N/A
Operator	To operate the	To operate the device the	No information publicly	Same	N/A
	devices the trainermust complete anXBody US EMS	trainer must complete anXBody US EMS TrainerCourse. The certification	available
	Trainer Course. Thecertification data	data received at the end ofthe course is required
	received at the endof the course is	when XBody registerstrainers in the device
	required whenXBody registers	database. Only registeredtrainers can start training
	trainers in the devicedatabase. Only	stimulation Programsusing a passcode.
	registered trainerscan start training
	stimulationPrograms using a
	passcode.
Display	GO: <10.5" LCDdisplay on theXBody Go USAtablet>PRO: <12.3" LCDdisplay on theXBody Pro USAtablet >	10.4" resistivetouchscreen	No information publiclyavailable	Different. Subject devices havebigger screens with capacitiveLCD touch screens providingmore accurate touch reading	Similar
StatisticalFunctions	Training data(trainer, client,date,duration). Clientrelated data.Number of trainingsessions (today,	Training data (trainer,client,date, duration).Client related data.Number of trainingsessions (today,yesterday,this week, this month,total).	No information publiclyavailable	Same	N/A
	yesterday, this week,this month, total).
Outputspecifications	Max Output Voltage	Max Output Voltage =20.8V @500 $\Omega$	Max Output Voltage =30V @500 $\Omega$	Max Output Voltage= 62.5V @500 $\Omega$	Similar. Subject devices havelower max output voltage.This particular feature hasalready been tested to IEC	Different. Subject devices havelower max output voltage.This particular feature hasalready been tested to IEC

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Max Output Current	Max Output Current =60mA @500Ω	Max Output Current= 125mA @500Ω	60601-1:2005+ A1:2012+A2:2020. This difference doesnot raise any concern for safetyand effectiveness.Similar. Subject devices havelower max output current. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.	60601-1:2005+ A1:2012+A2:2020. This difference doesnot raise any concern for safetyand effectiveness.Different. Subject devices havelower max output current. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.
Max Phase Charge= 16.64μC@500Ω	Max Phase Charge= 24μC@500Ω	No information publiclyavailable	Similar. Subject devices havelower max phase charge. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.	N/A
Max CurrentDensity =0.65mA/cm2@500Ω	Max Current Density =0.61mA/cm2 @500Ω	Max Current Density=1.92mA/cm2 @500Ω	Similar. Subject devices havelower max current density. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.	Different. Subject devices havelower max current density. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.
Max Power Density=3.46mW/cm2@500Ω	Max Power Density =7.27mW/cm2 @500Ω	Max Power Density =9.61mW/cm2 @500Ω	Similar. Subject devices havelower max power density. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.	Different. Subject devices havelower max power density. Thisparticular feature has alreadybeen tested to IEC 60601-1:2005+ A1:2012+ A2:2020.This difference does not raiseany concern for safety andeffectiveness.
				effectiveness.	effectiveness.
Net Charge (µCper pulse)	0 @500Ω(each phase usessymmetricwaveform)	0 @500Ω(each phase usessymmetric waveform)	Information NotAvailable	Same	N/A
Shape	Rectangular	Rectangular	Rectangular	Same	Same
Number of Outputchannels	6 output channels,but 12independentlyregulated outputs	10 individual,galvanically isolatedchannels for each output	l output channel canshift intime to 10 outputs,but electrical current canbe regulated individuallyon every output	Similar	Different. Subject devices havemore independently regulatedoutput channels.
Waveform	Symmetric biphasic	Symmetric biphasic	Symmetric biphasic	Same	Same
Burst mode -Pulses per burst	100 * 10 = 1000	100 * 10 = 1000	Information NotAvailable	Same	N/A
Burst mode -Bursts per second	0.1	0.1	Information NotAvailable	Same	N/A
Burst mode - Burstduration (seconds)	11	11	Information NotAvailable	Same	N/A
Burst mode - ONTime (seconds)	10	10	Information NotAvailable	Same	N/A
Burst mode - OFFTime (seconds)	1	1	Information NotAvailable	Same	N/A
Burst mode - DutyCycle:Line (d)/(Line (d)+Line (e))*	0.91	0.91	Information NotAvailable	Same	N/A
AdditionalFeatures (specify,if applicable)	N/A	N/A	N/A	N/A	N/A
Output frequency	1-150Hz	1-100Hz	1-100Hz	Different. Object devices providebetter customization through awider spectrum of output	Different. Object devices providebetter customization through awider spectrum of output
Positive pulse width	50-500usec	50-400usec	100-400usec	frequency.During the summative evaluation, the users evaluated the feeling of stimulation positively.The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. Therefore, the difference would not affect safety and effectiveness of the subject device.	frequency.During the summative evaluation, the users evaluated the feeling of stimulation positively.The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. Therefore, the difference would not affect safety and effectiveness of the subject device.
				Different. Object devices provide better customization through a wider spectrum of positive pulse width.During the summative evaluation, the users evaluated the feeling of stimulation positively.The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+ A2:2020. Therefore, the difference would not affect safety and effectiveness of the subject device.	Different. Object devices provide better customization through a wider spectrum of positive pulse width.During the summative evaluation, the users evaluated the feeling of stimulation positively.The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+ A2:2020. Therefore, the difference would not affect safety and effectiveness of the subject device.
Negative pulsewidth	50-500usec	50-400usec	100-400usec	Different. Object devices providebetter customization through awider spectrum of negative pulsewidth.During the summative evaluation,the users evaluated the feeling ofstimulation positively.The main output parameters(output current and output voltage) are lower for the subject devicesthan for the primary predicate andreference device. This particularfeature has already been tested toIEC 60601-1:2005+ A1:2012+A2:2020. Therefore, the differencewould not affect safety andeffectiveness of the subject device.	Different. Object devices providebetter customization through awider spectrum of negative pulsewidth.During the summativeevaluation, the users evaluatedthe feeling of stimulationpositively.The main output parameters(output current and outputvoltage) are lower for the subjectdevices than for the primarypredicate and reference device.This particular feature hasalready been tested to IEC60601-1:2005+ A1:2012+A2:2020. Therefore, thedifference would not affect safetyand effectiveness of the subjectdevice.
Power source –Battery	Li-ion 4x 3.7V (3.4Ah)	12V 10Ah LiFePO4battery in sealed housing.The battery is housed inthe stand that contains thedevice control panel. Thebattery can only becharged if disconnectedfrom the stand.	LiPo 3.7V (2.4Ah)	Similar. Both the predicate andsubject devices use rechargeablebatteries. For the subject device, aLi-ion battery was selected due toits light weight and compatibilitywith the compact design.	Similar
Size of theelectrodes	Predefined electrodesizes inside thetraining suitdescribed in UserManual	Predefined electrode sizesinside the training suitdescribed in User Manual	No information publiclyavailable	Similar	N/A
Safety circuits
	Overload tripdetects short-circuit,	Overload trip detectsshort-circuit, No-load trip	Software/Firmware/Micro processor Control: Yes	Same	Different, subject devicesutilize a wider range of safetyfeatures
	No-load trip detectscircuit break, battery	detects circuit break,battery voltage	Automatic Overload Trip:Yes
	voltage monitoring,	monitoring, hardware	Automatic Shut Off:On/Off switch
	hardware errordetection at startup,	error detection at startup,and watchdog	Patient Override Control:Yes, push on On/Offbutton directly pause theprogram
	and watchdogmonitoring.	monitoring.
Plugs	The XBody GoUSA and XBodyPro USA tablets andthe XBody ActiwearG2 wirelessstimulation unit areconnectedwirelessly. TheXBody Actiwear G2and the XBodyTraining Suit areconnected withmagneticconnectors. Theinternal cable of thetraining suitconnects to snapfasteners in the suitto which detachableelectrodes areattached viawaterproofconnections.	A spiral cable connectsthe device control unit tothe training suit. Theinternal cable of thetraining suit connects tosnap fasteners in the suitto which detachableelectrodes are attachedvia waterproofconnections.	No information publiclyavailable	Different. Primary predicate hasbuilt-in control panel, while thesubject device connectswirelessly with the control unit.The subject devices are worn bythe client, therefore no spiralcable is needed to connect withthe training suit.	N/A
Lead Wires -Cables	TS2.1: PVC coatedultra-flexible LIFY0,50 mm2 (256 x0,05 mm) cables andLiYY 0,56mm2 (7 x	PVC coated ultra-flexibleLIFY 0,50 mm2 (256 x0,05 mm) cables andLiYV 0,56mm2 (7 x 0,32mm) in the training suit.	No information publiclyavailable	Similar. The subject devices areworn by the client, therefore nospiral cable is needed to connectwith the training suit. The wiresin the predicate device and TS	N/A
	0,32 mm) in thetraining suit. Cablesare compliant withprotected lead wireand patient cablesafety requirementsTS3.0: Suit cable:Ultra-flexibleMicrominiature &Miniature PVCInsulated Lead WireTextile material(yarn): Polyester	Spiral cable withLi12Y11Y25 x 0,14mm2. Cables arecompliant with protectedlead wire and patientcable safety requirements		2.1 are the same.The wires in the predicate andthe TS 3.0 are similar toeachother.
Conductivity of theElectrodes	The client mustwear an XBodycotton underwear(biocompatibilitycertified). Theelectrodes arecontained in cottoncovers which mustbe watered usingnormal tap water tocreate conductivemedia. The cottontextiles hold enoughwater to provideconductivity duringthe training. Theelectrodes arewashable and can bedisinfected, asdescribed in UserManual.	The client must wear anXBody cotton underwear(biocompatibilitycertified). The electrodesare contained in cottoncovers which must bewatered using normal tapwater to create conductivemedia. The cotton textileshold enough water toprovide conductivityduring the training. Theelectrodes are washableand can be disinfected, asdescribed in User Manual.	No information publiclyavailable	Same	N/A
Soldering of thePrinted CircuitBoards	In accordance withthe ROHS directive,no leadsoldermaterial used.	In accordance with theROHS directive, no leadsolder material used.	No information publiclyavailable	Same	N/A
Placement of theelectrodes	The electrodes arelocated at fixedpositions in thetraining suitensuring properplacement.	The electrodes are locatedat fixed positions in thetraining suit ensuringproper placement.	No information publiclyavailable	Same	N/A
Reusable pads	Yes	Yes	Yes	Same	Same
Number ofprograms	XBody Go USA: 5XBody Pro USA: 6	4+10	20	Same to Go USA;Similar to Pro USA	DifferentXBody devices has a manualprogram that provides a broaderrange of stimulation parameterswhich ensures a more customizedtraining experience compared tothe 20 training programs withfixed stimulation parameters of theWiemspro.
Treatmentduration	1 min to 60 minmaximum	1 min to 60 min maximum	No information publiclyavailable	Same	The treatment duration isidentical to the primary predicatedevice.
Environment(s) ofuse	Home healthcareenvironment,according to IEC60601-1-11	Home healthcareenvironment, according toIEC 60601-1-11	No information publiclyavailable	Same	The environment of use isidentical to the primary predicatedevice.
Pulse duration	1-10 s	1-10 s	No information publiclyavailable	Same	The pulse duration is identical tothe primary predicate device.
Compliancestandards	IEC 60529:1989+A2:2013+C1:2019IEC 60601-1:2005+A1:2012+A2:2020IEC 60601-1-2:2014+A1:2020IEC 60601-1-6:2010+A1:2013+A2:2020IEC 60601-1-11:2015 +A1:2020IEC 60601-2-	IEC 60601-1:2005 + C1 +C2 + A1,IEC 60601-1-2:2014,IEC 60601-1-6:2010 +A1:2013,IEC 60601-1-11:2015,IEC 60601-2-10:2012 +A1:2016,IEC 62366:2007 +A1:2014	IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006ISO 14971:2007ANSI/AAMI ES60601-1:2005 / A2:2010	Since the predicate device is awired device, wireless CoexistenceQoS and Coexistence testing wasnot required. Due to the subjectdevice's wi-fi capability, it wasalso tested for additionalstandards, such as ANSI/AAMITIR 69:2017, IEEE/ANSI C63.27-2017 and ANSI/AAMITIR57:2016. The standards areFDA-recognized and align with	Due to the subject device's wi-ficapability, it was also tested foradditional standards, such asANSI/AAMI TIR 69:2017,IEEE/ANSI C63.27-2017 andANSI/AAMI TIR57:2016. Thestandards are FDA-recognizedand align with the GuidanceDocument "Radio FrequencyWireless Technology in MedicalDevices". This ensures the
	IEC 62304:2006+A1:2015IEC 62366-1:2015+A1:2020ANSI/AAMI TIR69:2017IEEE/ANSI C63.27-2017ANSI/AAMI TIR57:2016			Frequency Wireless Technology in device's overall safety andMedical Devices". This ensuresthe device's overall safety andeffectiveness.	effectiveness.
Automatic No-Load Trip	YES	YES	YES	Same	Same
Number of OutputModes	One output mode,but with varyingstimulationfrequency and dutycycle ranges	One output mode, but withvarying stimulationfrequency and duty cycleranges	One output mode, butwith varying stimulationfrequency and duty cycleranges	Same	Same
Total Dimensions(in.) [W x H x D]	9.65 X 6.9 X 0.33(tablet)1.96 X 1.96 X 0.98(Actiwear G2)	15.74 X 18.11 X 10.63	6.66 X 3.27 X 1.18	Different, subject devices aresmaller for a more compactdesign.	Different, subject devices aresmaller for a more compactdesign.
Housing Materialsand Construction	Plastic	Composite	Plastic	Different, subject devices haveplastic housing. As a result of itsdurability, heat resistance, andlow maintenance requirements,plastic was chosen as the housingfor the subject device.	Same
Footnote: In Table 1, N/A (not available) means that the comparison cannot be made to one of the predicate devices because information is not publicly available.

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Table 2 Comparison of Predicate and Subject Training Suit 2.0, XBody Training Suit 2.1 and XBody Training Suit 3.0

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Training suit	Training Suit 2.0Predicate Training Suit, Cleared forXBody Newave USA (K190038)	Training Suit 2.1 &Training Suit 3.0	Assessment
Compatible product	XBody Newave USA	XBody Go USAXBody Pro USA	Same
Parts	Vest, pants, optional bands	Vest, pants, optional bands	Same
Material	75% Polyamide, 25% Polyester	TS 2.1: 75% Polyamide, 25% Polyester(Same as TS 2.0)TS 3.0: 40 % Polyamide, 30 % Acrylic,25 % Polyester, 5 % Elastane	Similar
Underwear requiredduring use	Yes, same underwear for XBody GoUSA and Xbody Pro USA. Underwearserves as barrier to direct contact withthe body during use.	Yes, same underwear for XBodyNewave USA (K190038). Underwearserves as barrier to direct contact withthe body during use.	Same
Number of channels	10	12	Similar, but more available channels
Number of electrodes	20 pieces per suit	24 pieces per suit	Similar, but more available electrodes
Weight withelectrodes and cables	3 kg (6.6 lbs)	TS2.1: 2.7 - 3.3 kg (6 - 7.3 lbs.)TS3.0: 1.8 - 2.4 kg (4 - 5.3 lbs.)	Similar
Available Sizes	XXS, XS, S, M, L, XL	TS2.1: XXXS, XS, S, M, L, XL, XXLTS3.0: 2, 3, 3-L, 4, 4-L, 5, 5-W, 6, 7, 8	Similar, but wider range of sizes
Available ElectrodeSizes and Shapes	5 different electrode shapes	TS2.1: 8 different electrode shapesTS3.0: 10 different electrode shapes	Similar, but wider range of electrodesizes and shapes

The attributes of the Training Suit 2.1, which has "Similar" assessment results are supported by performance testing.

The XBody Training Suit 2.0 is the suit cleared for XBody Newave USA and is similar to XBody Training Suit 2.1 and to XBody Training Suit 3.0 in terms of its intended use. The XBody Training Suit 2.1 and the XBody Training Suit 3.0 material and number of electrodes are similar but not the same as those of the 2.0 version. XBody Training Suit 3.0 includes Acrylic and Elastane to improve comfort during use and a trimmer shape to lessen the total weight. The material of Training Suit 2.1 is the same as of the Training Suit 2.0. In addition, the size of the electrodes for the XBody Training Suit 3.0 are larger and shaped to improve comfort but without affecting performance or safety. The XBody Training Suit 2.1 utilizes the same electrodes as the XBody Training Suit 2.0 but has additional electrode types to improve comfort. The output specifications (i.e., maximum voltage, output current, plase charge, current density, and power density) for the XBody Pro USA with either XBody Training Suts are in the approximate

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ranges of XBody Newave USA using the XBody Training Suit 2.0 predicate and less than the same electrical parameters for the WiemsPro reference device.

Table 3Similarities of XBody Go USA and XBody Pro USA and Comparison to Primary Predicate Control Panel Parameters
Parameter	XBody Go USA(Subject Device)	XBody Pro USA(Subject Device)	Comparison ofSubject Devices	Subject Devices vs.XBody Newave USA
Control Unit	Microsoft Surface	Microsoft Surface	Same	Similar, built for XBNewave
Dimensions ofControl Unit	9.65" x 6.9" x 0.33" (245 mm x 175 mmx 8.3 mm)	11.5" x 7.9" x 0.33" (292 mm x 201mm x 8.5 mm)	Similar	Different, predicatenot a tablet
WirelessStimulation Unit	XBody Actiwear G2	XBody Actiwear G2	Same	Similar, but predicatenot wireless
Training Suit	Able to use XBody Training Suit 2.1 orXBody Training Suit3.0	Able to use XBody Training Suit 2.1 orXBody Training Suit 3.0	Same	Different, predicateuses TS2.0
Requirement forUnderwear	XBody Underwear must be worn duringuse.	XBody Underwear must be worn duringuse.	Same	Same
TrainingPrograms	Manual settings, Muscle Development,Endurance, Relax, Professional trainingprograms	Manual settings, Muscle Development,Endurance, Relax, Professional, XBeattraining programs	Similar	Similar
ProfessionalTraining Features	In person, Virtual trainer, Video editor	In person, Virtual trainer, Video editor	Same	Similar
User Manual	Yes, content varies based on devicedesign	Yes, content varies based on devicedesign	Similar	Similar
Maximumnumber ofSimultaneousClients	1-2 persons	1-6 persons	Similar	Similar, 1 person forthe predicate
Control PanelStorage	Tablet: 64 GB	Tablet: Solid-state drive: 128GB	Similar	Different: Box
Control PanelDisplay	10.5-inch Tablet Screen	12.3-inch Tablet Screen	Similar	Similar
Control PanelBattery Life	Up to 9 hours of typical device usage	Up to 15 hours of typical device usage	Similar	Different, predicatehas Mains PowerSource
Control PanelCamera	5.0MP front-facing camera with 1080pSkype HD video;8.0MP rear-facing autofocus camerawith 1080p HD videoDual Studio Mics2W stereo speakers with Dolby® Audio	5.0MP front-facing camera with 1080pfull HD video;8.0MP rear-facing autofocus camerawith 1080p full HD videoDual far-field Studio Mics1.6W stereo speakers	Similar	Different: No Camera
Wireless type	Wi-Fi: IEEE 802.11a/b/g/n/ac/axBluetooth Wireless 5.0 technology	Wi-Fi 6: 802.11ax compatibleBluetooth Wireless 5.0 technology	Similar	N/A
Weight of ControlUnit	1.2 lbs. (544 g)	1.70 lbs. (775 g)	Similar	Different, uses a stand

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The following is a comparison of the similarities of XBody Pro USA and XBody Newave USA as listed in Table 3.

Control unit: XBody Newave USA works with self-made hardware (XBody Newave USA Head) instead of the XBody Go USA and XBody Pro USA systems, the control unit is a Microsoft Surface tablet which is marked as Go 2 or Pro 7+, ontans XBody-related software to restrict use only to XBody training, and includes a camera for both units.

Wired and wireless technology: XBody Newave USA works only with a wired configuration, such that the Training Suit 2.0 and the XBody Newave USA head are connected via a spiral cable. In the case of the XBody Pro USA systems, there is a new part of the system, the XBody Actiwear G2. XBody Actiwear G2 communicates with the tablets via Wi-Fi.

Camera: XBody Newave USA does not have a camera. The XBody Pro USA use the Microsoft Surface cameras.

Number of clients: Using the XBody Newave USA's wired technology, only one client can train at a time. With XBody Go USA only two clients can work out together wirelessly at the same time and with the XBody Pro USA, as many as six clients can tran simultaneously.

Software: The subject devices have similar software platforms with some additional programing for the XBody Pro USA compared to XBody Go USA and both predicates, which includes for example the UPBEAT program for audio musical accompaniment to the workout and ability to support group training sessions.

Assessment: Compared to XBody Newave USA, XBody Go USA and XBody Pro USA are similar in intended use, performance, design,

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dimensions, and materials as the predicate device. The new device meets the same standards for safety as the predicate device.

Table 4Standard Number and Title Used to SupportXBody Go USA and XBody Pro USA Safety and Performance
Standard Number	Applied Standards by Title
ANSI/AAMI 60601-1:2005/(R)2012 andA1:2012.	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance
IEC 60601-1-2:2014+A1:2020	Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-6:2010+ A1:2013+A2:2020	Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance -Collateral standard: Usability
IEC 60601-1-11:2015+A1:2020	Medical electrical equipment -- Part 1-11: General requirements for basic safety andessential performance – Collateral standard: Requirements for medical electricalequipment and medical electrical systemsused in the home healthcare environment
IEC 60601-2-10:2012+A1:2016	Medical electrical equipment - Part 2-10: Particularrequirements for the basicsafety and essential performance of nerve and muscle stimulators
IEC 62366-1:2015+A1:2020	Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62304:2006+A1:2015	Medical device software - Software life cycle Processes
IEC 60529:1989+A2:2013+ C1:2019	Degrees of Protection Provided by enclosures (IP Code)
EN ISO 14971:2019	Medical devices - Application of risk management to medical devices.
ISO 10993-1	Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Withina Risk ManagementProcess (Biocompatibility).
ISO 10993-5	Biological evaluation of medical devices - part 5: testsfor in vitro cytotoxicity.
ISO 10993-10	Biological evaluation of medical devices - part 10: testsfor irritation and skin sensitization.
EN ISO 14971:2019	Medical devices - Application of risk management to medical devices.
EN ISO 13485:2016	Medical Devices – Quality Management Systems -requirements for regulatorypurposes
FDA Guidance	Food and Drug Administration Guidance for theContent of PremarketSubmissions for SoftwareContained in Medical Devices 2005
FDA Guidance	Guidance for Industry, FDA Reviewers/Staff andCompliance Guidance Document for Powered MuscleStimulator 510(k)s, June 9,1999

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G. Conclusion of Substantial Equivalence

Electrical safety and electromagnetic compatibility of the XBody Pro USA devices are supported by independent testing per international standards, which included the XBody Actiwear G2 unit and XBody Training Suits 2.1 and 3.0.

The subject devices and the primary predicate and reference devices differ in their software of the subject devices has been validated to IEC 62304:2006+A1:2015. Based on the independent electrical and electromagnetic compatibility testing and the performance testing of the subject devices, these software differences are directed at fulfilling intended use in a user-friendly interface that does not affect the safety and effectiveness.

Performance testing of the Training Suit 3.0 demonstrated acceptable similarity in intended use to the Training Suit 2.0 that was cleared for the XBody Newave USA Predicate.

Differences in the structures of the control units (i.e., stand-alone fabricated unit vs. modified commercial tablet) between the XBody subject devices and the XBody Newave USA predicate device are mainly due to improvements in design and programming of user interface which are supported by usability performance testing.

The Applied Part is the Underwear required to be wom under the XBody Training Suit 2.1 and the XBody

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Training Suit 3.0. The 2.0 version was cleared under K190038 per ISO biocompatibility standards.

The Power source for the two subject devices is a rechargeable battery that is supported by bench and is similar in function and safety to the WiemsPro predicate device. The Microsoft Surface camera for the two subject devices is different than that for the two predicates. This has no bearing on device safety and performance.

Conclusion: XBody Go USA and XBody Pro USA are substantially equivalent to their predicate devices. Differences between the subject and predicate devices do not affect safety or performance.

END OF DOCUMENT.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).