The XBODY NEWAVE 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 people (clients), not for rehabilitation purposes.

The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE 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 NEWAVE USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The XBODY NEWAVE USA electrical impulses allow the triggering of action potentials on motoneurons of 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 contraction, 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 NEWAVE USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY NEWAVE USA may therefore be considered a technique of muscle training.

Device Description

AI/ML Overview

This document is a 510(k) premarket notification for the XBODY NEWAVE USA device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device, a common pathway for medical device approval where the device is shown to be as safe and effective as a legally marketed device.

Therefore, I cannot extract the requested information using only the provided text, as it describes a different type of regulatory submission. The request asks for details typically found in AI/ML performance studies, which are not present in this 510(k) for a powered muscle stimulator.

Here's why the document doesn't contain the requested information:

Device Type: The XBODY NEWAVE USA is a "Powered Muscle Stimulator" (Product Code NGX, Regulation Number 21 CFR 890.5850). This is a physical device, not an AI/ML algorithm.
Regulatory Pathway: The document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device. This typically involves comparing technological characteristics, intended use, and safety/performance standards. It does not require a clinical study with acceptance criteria for AI/ML performance metrics like sensitivity, specificity, accuracy, or reader improvement.
Absence of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any data-driven diagnostic or prognostic capabilities. The document details electrical impulses, physical parameters, user interfaces, and safety standards for the muscle stimulator.

To answer your request, I would need a document describing the regulatory submission for an AI/ML medical device, which would include performance metrics and clinical validation studies.

Summary

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April 5, 2019

XBody Hungary Kft. % R. William Soller President Biomedical Regulatory Consulting 9203 Hwy 6 South, Suite 124 Houston, Texas 77083

Re: K190038

Trade/Device Name: Xbody Newave USA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 1, 2018 Received: January 8, 2019

Dear R. William Soller:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190038

Device Name XBODY NEWAVE 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

General Information A.

Sponsor's Name:	XBody Hungary Kft.
Sponsor's Contact Person:	Péter Tar
	Research & Development Manager
Address:	György Aladár u. 35-39
	Budapest, Hungary 1125
	peter.tar@xbodyworld.com
	www.xbodyworld.com
US Contact Person:	R. William Soller, PhD
Address:	Biomedical Regulatory Consulting
	9203 Hwy 6 South, Suite 124
	Houston, Texas 77083
	CELL (713) 380-7146
	FAX (888) 370-5065
	rwsoller@biomedreg.com

B. Device

Trade Name:	XBODY NEWAVE USA
Common Name:	Stimulator, Muscle, Powered
Product Code:	NGX
Class:	2
Regulation Number:	21 CFR 890.5850

C. Identification of Legally Marketed Predicate Device

Name:	E-Fit EF-1280
Manufacturer:	FIT PRO, LLC
K Number:	K133225

D. Description of the Device

E. Indication for Use (Same as Predicate)

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The XBODY NEWAVE 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 responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

F. Technological Characteristics

Compared the to the predicate device, XBODY NEWAVE USA is similar in intended use, performance, design, dimensions, and materials as the predicate device. The new device meets the same standards for safety as the predicate device.

Parameter /Application	XBODY NEWAVE USA	E-Fit EF-1280, Predicate(K133225)	Assessment ofSubstantialEquivalence
Powered MuscleStimulator	Yes	Yes	Same
Regulated	Yes	Yes	Same
Output specification	Max Output Voltage =30 V @500Ω	Max Output Voltage = 36V @500Ω	Similar
	Max Output Current =60 mA @500Ω	Max Output Current = 72mA @500Ω	Similar
	Max Phase Charge =24μC@500Ω	Max Phase Charge = 36μC@500Ω	Similar
	Max Current Density =0.61mA/cm2 @500Ω	Max Current Density =0.85mA/cm2 @500Ω	Similar
	Max Power Density =7.27mW/cm2 @500Ω	Max Power Density =6.3mW/cm2 @500Ω	Similar
Max Output Current	60 mA	72 mA	Similar
Max Output Voltage	50V	0-36V	Similar
Number of channels	10 individual, galvanicallyisolated channels for eachoutput	1 output channel can shift intime to the 12 outputsbut electrical current canbe regulated individuallyon every output	Similar
Waveform	Symmetric biphasic	Symmetric biphasic	Same
Output frequency	1-100Hz	5-120Hz	Similar
Positive pulse width	50-400usec	100-500usec	Similar
Negative pulse width	50-400usec	100-500usec	Similar
Number of programs	4+10	5+5	Similar
Program durations	1 min to 60 min maximum	1 min to 30 min maximum	Similar
Power source -Battery	12V 10Ah LiFePO4 batteryin sealed housingThe battery is housed in thestand that contains thedevice control panel. Thebattery can only be chargedif disconnected from thestand.	12V (3.4Ah) Lead Acid	Similar
Size of the electrodes	Predefined electrode sizesinside the training suitdescribed in User Manual	Electrodes withpre-defined (supplied withthe device) size andcorrect position.	Similar
User interface	The device can be controlledusing graphical windowsappearing on the touchscreenof the device. On thetraining screen wherestimulation controls can beused the START/ STOPbuttons are large and easilycontrollable. Stimulationcontrols for adjustingchannel intensities, and allother stimulation parametersare clearly visible and easilycontrollable. Channelidentification is supportedwith big pictures showingthe selected muscle groups.When the stimulation is on,the STOP button is alwaysvisible and accessible.	The rotary encoder allowsfor a quick set-up andbecause of the push buttoncapability, the program canbe stopped immediately forevery channel. There arelarge START/STOP andPOWER off buttons to beginthe program and for completepower shutdown. Because of the pictographs and fixedelectrodes in the clothing, it isvery easy to set theappropriate muscle groups.	Similar
Safety circuits	No load trip, overload tripdetects short-circuit andcircuit break, battery voltage	Short-circuit monitoring,watchdog monitoring,no load trip, no load trip	Same
	monitoring hardware errordetection at startup, andwatchdog monitoring	battery monitoring,battery voltagemonitoring, outputcurrent monitoring(emergency STOP option),option for self-test,hardware errormonitoring
Portability/MobileUse	The device is portable (17lbs), but it is not a mobiledevice. Its intended userequires presence of aqualified and trainedoperator.	The device is portable withdifficulty. It is not amobile device. Its intendeduse requires the qualifiedandtrained operator.	Same
Material of theenclosure	Composite	Stainless steel	Similar
Intended use	The XBODY NEWAVEUSA is intended to stimulatehealthy muscles in order toimprove or facilitate muscleperformance.	EF 1280 is intended tostimulate healthy musclesin order to improve orfacilitate muscleperformance.	Same
Operator	To operate the device thetrainer must complete anXBody Trainer Course. Thecertification data received atthe end of the course isrequired when XBodyregisters trainers in thedevice database. Onlyregistered trainers can starttraining stimulationprograms using a passcode.	By manufacturerecommendations, theonly person who canoperate the device mustobtain certificationsprovided by the seller.This person mustcomplete the certificationprior to use on a patient.	Same
Menu / Settings	Easy-to-use multi-choicemenu for registered andcertified trainers tocustomize trainingparameters and stimulationprograms.	Simple one-level menusystem	Similar
Plugs	A spiral cable connects thedevice control unit to thetraining suit. The internalcable of the training suitconnects to snap fasteners inthe suit to which detachableelectrodes are attached viawaterproof connections.	Cables connect to theelectrodes with snapfastener and connect tothe machine with plastic12pin waterproof ip68connector.	Similar
Lead wires - cables	PVC coated ultra-flexibleLIFY 0,50 mm2 (256 x 0,05mm) cables and LiYV 0,56	SIFF 1-1.5mm2 (1x375unique filaments) ultraflexible - Compliant withprotected lead wire and	Similar
	mm2 (7 x 0,32 mm) in thetraining suit.Spiral cable with Li12Y11Y25 x 0,14 mm2.Cables are compliant withprotected lead wire andpatient cable safetyrequirements	patient cable safetyrequirements
Conductivity of theelectrodes	The client has to wear anXBody cotton underwear(biocompatibility certified).The electrodes are containedin cotton covers which mustbe soaked/ irrigated usingnormal tap water to createconductive media. Thecotton textiles holds enoughwater to provide conductiv-ity during the training. Theelectrodes are washable andcan be disinfected, asdescribed in User Manual.	The subject needs to puton an 100% hygroscopiccotton underwear (surgerytextile, biocompatibilitycertified) and theseunderwear need to besoaked/ irrigated withnormal tap water. So theelectro conductive media issimply tap watered cottonwhich is in contact with theelectrodes. The surface ofthe electrode will not getdry. In this case the pulsetransmission efficiency willnot decrease. The smallconductive pads arewashable and can bedisinfected	Same
Soldering of thePrinted CircuitBoards	In accordance with theROHS directive, no leadsolder material used.	According to the ROHSdirective there is no leadsolder material used.	Same
Placement of theelectrodes	The electrodes are located atfixed positions in thetraining suit ensuring properplacement.	Appropriately pre-placedin specific areas accordingto muscle anatomy.	Similar
Reusable pads	Yes	Yes	Same
Display	10.4" resistive touchscreen	LCD 2x40 character LCDdisplay with LED backlight	Similar
Statistical Functions	Training data (trainer, client,date, duration).Number of trainings (today,yesterday, this week, thismonth, total).	Statistical functions –counting the hours ofoperation	Similar

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The identified differences between subject and predicate devices are minimum. Output specifications of the subject device are similar to the predicate and meet the IEC safety requirements for powered muscle stimulators. Stimulation parameters are similar, allowing substantially equivalent muscle work to be achieved by the subject device. The subject device provides channel isolation galvanically which ensures that each pair of electrodes

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define proper current path in the body. Hence, the XBody choice of existing technology is substantially equivalent to time shifting used by the predicate. LiFePo4 batteries of the XBody device have a longer cycle-life and are more durable than Lead Acid batteries used by the predicate. The menu and the user interface of both devices are similar, easily operable and therefore known to the operators. Statistic reports from XBody NEWAVE USA are more detailed than the predicate, to enhance usability. The material of XBody stand and enclosure is made of durable composite, with similar function of the predicate.

G. Summary of Testing and Comparison to the Predicate Device

XBODY NEWAVE USA is designed and manufactured in accordance with the application of the following standards and FDA guidances.

Standard Number	Applied Standards by Title	FDARecognitionNumber
ANSI/AAMI 60601-1:2005/(R)2012 and A1:2012	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance	19-4
IEC 60601-1-2:2007.	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances -Requirements and tests	19-8
IEC 60601-1-6:2010 (ThirdEdition) + A1:2013	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability	5-89
IEC 60601-1-11:2015	Medical electrical equipment -- Part 1-11: Generalrequirements for basic safety and essential performance-- Collateral standard: Requirements for medicalelectrical equipment and medical electrical systemsused in the home healthcare environment	19-14
IEC 60601-2-10:2007 +AMD1 2012.	Medical electrical equipment - Part 2-10: Particularrequirements for the basic safety and essentialperformance of nerve and muscle stimulators	17-16
IEC 62366:2007 + A1: 2014.	Medical devices – Application of usability engineeringto medical devices	5-114
ASTM-F1980	Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices	14-497
ISO 10993-1	Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk ManagementProcess. (Biocompatibility)	2-156
ISO 10993-5	Biological evaluation of medical devices - part 5: testsfor in vitro cytotoxicity.	2-153
ISO 10993-10	Biological evaluation of medical devices - part 10: testsfor irritation and skin sensitization.	2-173
ISTA 3E	General simulation test for unitized loads of the sameretail or institutional packaged-product	5-112
EN ISO 14971:2012.	Medical devices - Application of risk management tomedical devices	5-40

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EN ISO 13485:2003 /AC2009	Medical Devices – Quality Management Systems –requirements for regulatory purposes	N/A
Applied Guidances
FDA Guidance	Food and Drug Administration Guidance for theContent of Premarket Submissions for SoftwareContained in Medical Devices 2005	N/A
FDA Guidance	Guidance for Industry, FDA Reviewers/Staff andCompliance Guidance Document for Powered MuscleStimulator 510(k)s, June 9, 1999	N/A
FDA Guidance for Industryand FDA Staff:	Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process"	N/A

H. Conclusion

XBODY NEWAVE USA does not use any new technology. Differences between the subject device and its predicate are minimum and do not affectiveness (SE). The general information for the new device and the predicate is the same in terms of intended use, indications and principles of operation. There are minimum differences in the technological characteristics and performance data for the new device and the predicate; however, both devices comply with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 standards. Thus, these differences do not affect substantial equivalence between the devices.

Conclusion: XBODY NEWAVE USA is substantially equivalent to the predicate device.

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).