Xbody Newave USA

K190038 · Xbody Hungary Kft. · NGX · Apr 5, 2019 · Physical Medicine

Device Facts

• Record ID: K190038
• Device Name: Xbody Newave USA
• Applicant: Xbody Hungary Kft.
• Product Code: NGX · Physical Medicine
• Decision Date: Apr 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Powered muscle stimulator (EMS) for healthy muscle training; used as supplement to sports. Device delivers electrical impulses to motoneurons via electrodes in a training suit; triggers action potentials causing mechanical muscle fiber response. Operator (certified trainer) controls stimulation parameters (frequency, contraction/rest duration) via touchscreen interface. Output: symmetric biphasic electrical pulses. Benefits: improved/facilitated muscle performance. Used in clinical/training settings by trained operators. Safety features: galvanic channel isolation, no-load/overload/short-circuit detection, watchdog monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10 standards. Biocompatibility testing performed per ISO 10993-1, 10993-5, and 10993-10.

Technological Characteristics

Powered muscle stimulator; 10 galvanically isolated channels; symmetric biphasic waveform; frequency 1-100Hz; pulse width 50-400usec. 12V 10Ah LiFePO4 battery. 10.4" resistive touchscreen. Electrodes integrated into cotton training suit, activated by tap water. Enclosure: composite. Safety: no-load/overload/short-circuit detection, watchdog monitoring. Standards: ANSI/AAMI 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62366, ASTM-F1980, ISO 10993, ISTA 3E, EN ISO 14971, EN ISO 13485.

Indications for Use

Indicated for healthy individuals to stimulate healthy muscles to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles or in conjunction with therapy/treatment of medical diseases or conditions.

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

• E-Fit EF-1280 (K133225)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> |
| | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 |
| | [e-mail] |
| | www.xbodyworld.com |
| US Contact Person: | R. William Soller, PhD |
| Address: | Biomedical Regulatory Consulting |
| | 9203 Hwy 6 South, Suite 124 |
| | Houston, Texas 77083 |
| | CELL [phone] |
| | FAX [phone] |
| | [e-mail] |

#### 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

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 clients, not for rehabilitation purposes.

#### E. Indication for Use (Same as Predicate)

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 clients, not for rehabilitation purposes.

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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 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.

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.

#### 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 /<br>Application | XBODY NEWAVE USA | E-Fit EF-1280, Predicate<br>(K133225) | Assessment of<br>Substantial<br>Equivalence |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Powered Muscle<br>Stimulator | Yes | Yes | Same |
| Regulated | Yes | Yes | Same |
| Output specification | Max Output Voltage =<br>30 V @500Ω | Max Output Voltage = 36<br>V @500Ω | Similar |
| | Max Output Current =<br>60 mA @500Ω | Max Output Current = 72<br>mA @500Ω | Similar |
| | Max Phase Charge =<br>24μC@500Ω | Max Phase Charge = 36μC<br>@500Ω | Similar |
| | Max Current Density =<br>0.61mA/cm2 @500Ω | Max Current Density =<br>0.85mA/cm2 @500Ω | Similar |
| | Max Power Density =<br>7.27mW/cm2 @500Ω | Max Power Density =<br>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, galvanically<br>isolated channels for each<br>output | 1 output channel can shift in<br>time to the 12 outputs<br>but electrical current can<br>be regulated individually<br>on 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 -<br>Battery | 12V 10Ah LiFePO4 battery<br>in sealed housing<br>The battery is housed in the<br>stand that contains the<br>device control panel. The<br>battery can only be charged<br>if disconnected from the<br>stand. | 12V (3.4Ah) Lead Acid | Similar |
| Size of the electrodes | Predefined electrode sizes<br>inside the training suit<br>described in User Manual | Electrodes with<br>pre-defined (supplied with<br>the device) size and<br>correct position. | Similar |
| User interface | The device can be controlled<br>using graphical windows<br>appearing on the touchscreen<br>of the device. On the<br>training screen where<br>stimulation controls can be<br>used the START/ STOP<br>buttons are large and easily<br>controllable. Stimulation<br>controls for adjusting<br>channel intensities, and all<br>other stimulation parameters<br>are clearly visible and easily<br>controllable. Channel<br>identification is supported<br>with big pictures showing<br>the selected muscle groups.<br>When the stimulation is on,<br>the STOP button is always<br>visible and accessible. | The rotary encoder allows<br>for a quick set-up and<br>because of the push button<br>capability, the program can<br>be stopped immediately for<br>every channel. There are<br>large START/STOP and<br>POWER off buttons to begin<br>the program and for complet<br>epower shutdown. Because o<br>f the pictographs and fixed<br>electrodes in the clothing, it i<br>svery easy to set the<br>appropriate muscle groups. | Similar |
| Safety circuits | No load trip, overload trip<br>detects short-circuit and<br>circuit break, battery voltage | Short-circuit monitoring,<br>watchdog monitoring,<br>no load trip, no load trip | Same |
| | monitoring hardware error<br>detection at startup, and<br>watchdog monitoring | battery monitoring,<br>battery voltage<br>monitoring, output<br>current monitoring<br>(emergency STOP option),<br>option for self-test,<br>hardware error<br>monitoring | |
| Portability/Mobile<br>Use | The device is portable (17<br>lbs), but it is not a mobile<br>device. Its intended use<br>requires presence of a<br>qualified and trained<br>operator. | The device is portable with<br>difficulty. It is not a<br>mobile device. Its intended<br>use requires the qualified<br>and<br>trained operator. | Same |
| Material of the<br>enclosure | Composite | Stainless steel | Similar |
| Intended use | The XBODY NEWAVE<br>USA is intended to stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance. | EF 1280 is intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance. | Same |
| Operator | To operate the device the<br>trainer must complete an<br>XBody Trainer Course. The<br>certification data received at<br>the end of the course is<br>required when XBody<br>registers trainers in the<br>device database. Only<br>registered trainers can start<br>training stimulation<br>programs using a passcode. | By manufacture<br>recommendations, the<br>only person who can<br>operate the device must<br>obtain certifications<br>provided by the seller.<br>This person must<br>complete the certification<br>prior to use on a patient. | Same |
| Menu / Settings | Easy-to-use multi-choice<br>menu for registered and<br>certified trainers to<br>customize training<br>parameters and stimulation<br>programs. | Simple one-level menu<br>system | Similar |
| Plugs | A spiral cable connects the<br>device control unit to the<br>training suit. The internal<br>cable of the training suit<br>connects to snap fasteners in<br>the suit to which detachable<br>electrodes are attached via<br>waterproof connections. | Cables connect to the<br>electrodes with snap<br>fastener and connect to<br>the machine with plastic<br>12pin waterproof ip68<br>connector. | Similar |
| Lead wires - cables | PVC coated ultra-flexible<br>LIFY 0,50 mm2 (256 x 0,05<br>mm) cables and LiYV 0,56 | SIFF 1-1.5mm2 (1x375<br>unique filaments) ultra<br>flexible - Compliant with<br>protected lead wire and | Similar |
| | mm2 (7 x 0,32 mm) in the<br>training suit.<br>Spiral cable with Li12Y11Y<br>25 x 0,14 mm2.<br>Cables are compliant with<br>protected lead wire and<br>patient cable safety<br>requirements | patient cable safety<br>requirements | |
| Conductivity of the<br>electrodes | The client has to wear an<br>XBody cotton underwear<br>(biocompatibility certified).<br>The electrodes are contained<br>in cotton covers which must<br>be soaked/ irrigated using<br>normal tap water to create<br>conductive media. The<br>cotton textiles holds enough<br>water to provide conductiv-<br>ity during the training. The<br>electrodes are washable and<br>can be disinfected, as<br>described in User Manual. | The subject needs to put<br>on an 100% hygroscopic<br>cotton underwear (surgery<br>textile, biocompatibility<br>certified) and these<br>underwear need to be<br>soaked/ irrigated with<br>normal tap water. So the<br>electro conductive media is<br>simply tap watered cotton<br>which is in contact with the<br>electrodes. The surface of<br>the electrode will not get<br>dry. In this case the pulse<br>transmission efficiency will<br>not decrease. The small<br>conductive pads are<br>washable and can be<br>disinfected | Same |
| Soldering of the<br>Printed Circuit<br>Boards | In accordance with the<br>ROHS directive, no lead<br>solder material used. | According to the ROHS<br>directive there is no lead<br>solder material used. | Same |
| Placement of the<br>electrodes | The electrodes are located at<br>fixed positions in the<br>training suit ensuring proper<br>placement. | Appropriately pre-placed<br>in specific areas according<br>to muscle anatomy. | Similar |
| Reusable pads | Yes | Yes | Same |
| Display | 10.4" resistive touchscreen | LCD 2x40 character LCD<br>display with LED backlight | Similar |
| Statistical Functions | Training data (trainer, client,<br>date, duration).<br>Number of trainings (today,<br>yesterday, this week, this<br>month, total). | Statistical functions –<br>counting the hours of<br>operation | 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 | FDA<br>Recognition<br>Number |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| ANSI/AAMI 60601-1:2005/<br>(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | 19-4 |
| IEC 60601-1-2:2007. | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | 19-8 |
| IEC 60601-1-6:2010 (Third<br>Edition) + A1:2013 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Usability | 5-89 |
| IEC 60601-1-11:2015 | Medical electrical equipment -- Part 1-11: General<br>requirements for basic safety and essential performance<br>-- Collateral standard: Requirements for medical<br>electrical equipment and medical electrical systems<br>used in the home healthcare environment | 19-14 |
| IEC 60601-2-10:2007 +<br>AMD1 2012. | Medical electrical equipment - Part 2-10: Particular<br>requirements for the basic safety and essential<br>performance of nerve and muscle stimulators | 17-16 |
| IEC 62366:2007 + A1: 2014. | Medical devices – Application of usability engineering<br>to medical devices | 5-114 |
| ASTM-F1980 | Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices | 14-497 |
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing Within a Risk Management<br>Process. (Biocompatibility) | 2-156 |
| ISO 10993-5 | Biological evaluation of medical devices - part 5: tests<br>for in vitro cytotoxicity. | 2-153 |
| ISO 10993-10 | Biological evaluation of medical devices - part 10: tests<br>for irritation and skin sensitization. | 2-173 |
| ISTA 3E | General simulation test for unitized loads of the same<br>retail or institutional packaged-product | 5-112 |
| EN ISO 14971:2012. | Medical devices - Application of risk management to<br>medical devices | 5-40 |

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| EN ISO 13485:2003 /AC2009 | Medical Devices – Quality Management Systems –<br>requirements for regulatory purposes | N/A |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Applied Guidances | | |
| FDA Guidance | Food and Drug Administration Guidance for the<br>Content of Premarket Submissions for Software<br>Contained in Medical Devices 2005 | N/A |
| FDA Guidance | Guidance for Industry, FDA Reviewers/Staff and<br>Compliance Guidance Document for Powered Muscle<br>Stimulator 510(k)s, June 9, 1999 | N/A |
| FDA Guidance for Industry<br>and FDA Staff: | Use of International Standard ISO 10993-1, "Biological<br>evaluation of medical devices - Part 1: Evaluation and<br>testing 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.