(248 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as generating electrical impulses based on EMS technology, not through AI-driven models.
No
The device explicitly states that it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and is "not for rehabilitation purposes." It is designed for stimulating healthy muscles to improve performance.
No
The device is described as an electronic muscle stimulation machine intended for training healthy muscles and improving muscle performance, not for diagnosis of any condition.
No
The device is not a software-only medical device because it explicitly describes physical "machines with electronic muscle stimulation" and "electrical impulses" which necessitate hardware components for their function. While software updates are mentioned for user interface enhancements, the core functionality relies on physical EMS technology.
No.
The device is an EMS (Electrical Muscle Stimulation) machine used for fitness and muscle training, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications 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 only for healthy muscles and clients, 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 diseases or 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 their use on such muscles is contraindicated.
For both models, 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 Go USA and 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.
Product codes
NGX
Device Description
The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on electrical muscle stimulation (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home healthcare environment, according to IEC 60601-1-11
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility of the XBody Go USA and XBody Pro USA devices have been validated through independent testing in accordance with international standards. This testing covered the XBody Actiwear G2 main unit, the control unit, the XBody Training Suit 2.1, the XBody Training Suit 3.0 (all four used in both the subject and predicate devices), and the XBody DrySuit, which is newly included in this submission.
The subject devices and the predicate devices have the same software programming except for minor functionalities. The software of the subject devices has been updated to include a feature that allows users to select the DrySuit among the available training suits. Independent electrical and electromagnetic compatibility testing, along with performance testing of the subject devices, confirms that these software differences are aimed at enhancing the user interface without impacting safety and effectiveness.
Performance testing of the XBody DrySuit demonstrated acceptable similarity in intended use to the XBody Training Suit 2.1 and the XBody Training Suit 3.0, both of which were previously cleared for the XBody Go USA and XBody Pro USA predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter and Submission Summary
Page 1
May 30, 2025
XBody Hungary Kft.
℅ Bhoomika Joyappa
Senior Regulatory Consultant
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury, Vermont 05738
Re: K242926
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: September 20, 2024
Received: September 24, 2024
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Page 2
K242926 - Bhoomika Joyappa Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K242926 - Bhoomika Joyappa Page 3
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242926
Device Name
XBody Go USA, XBody Pro USA
Indications for Use (Describe)
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 only for healthy muscles and clients, 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 diseases or 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 their use on such muscles is contraindicated.
For both models, 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 Go USA and 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
Page 5
Premarket Notification [510(k) Summary]
A. General Information
Sponsor's Name: XBody Hungary Kft.
Sponsor's Contact Person: Orsolya Balog (Regulatory Compliance)
Address: György Aladár u. 35-39 Budapest, Hungary 1125
orsolya.balog@XBodyworld.com
www.XBodyworld.com
Submission Contact Person: Bhoomika Joyappa
Senior Regulatory Consultant
Address: Medical Device Academy, Inc
345 Lincoln Hill Rd,
Shrewsbury, VT 05738
bhoomika@fdaestar.com
Date Prepared: 5/28/2025
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
Regulation Number: 21 CFR 890.5850
C. Identification of Legally Marketed Predicate Device
Predicate Device: XBody Go USA, XBody Pro USA
Manufacturer: XBody Hungary Kft
Predicate 510(k) Number: K221200
Page 6
D. Description of the Devices
The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on electrical muscle stimulation (EMS) technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.
E. Indication for Use
The XBody Go USA and XBody Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used for only healthy muscles and clients, 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 diseases or 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 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 Go USA and 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 predicate devices, the XBody Go USA and XBody Pro USA are the same in indication for use, intended use performance, design, dimensions, and materials as the predicate devices. The new devices meet the same standards for safety and performance as the predicate devices.
The differences cited in the comparison tables between subject and predicate devices do not affect safety and performance of the subject devices when compared for equivalence to the predicate devices.
| Parameter/application | Subject Device XBody Go USA and XBody Pro USA | Predicate Device XBody Go USA and XBody Pro USA (K221200) | Assessment of substantial equivalence between Subject and Predicate Devices |
|---|---|---|---|
| 510k Number | NA | K221200 | NA |
Page 7
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Submitter | XBody Hungary Kft | XBody Hungary Kft | Same |
| Common or Usual Name | Powered muscle stimulator. | Powered muscle stimulator. | Same |
| Product code | NGX | NGX | Same |
| Classification Name | Stimulator, Muscle, Powered, For Muscle Conditioning | Stimulator, Muscle, Powered, For Muscle Conditioning | Same |
| Product Classification | Class II | Class II | Same |
| Review Panel | Physical Medicine | Physical Medicine | Same |
| Regulated voltage | Yes | Yes | Same |
| Regulation Name | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Indications 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 muscles and people (clients), not for rehabilitation purposes. The XBody Go USA and XBody Pro USA are intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBody Go USA and XBody Pro USA are 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 or XBody Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated. | 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 muscles and people (clients), not for rehabilitation purposes. The XBody Go USA and XBody Pro USA are intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBody Go USA and XBody Pro USA are 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 or XBody Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated. | Same |
Page 8
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Indications for use (continued) | The XBody 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 Go USA or XBody Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBody Go USA and the XBody Pro USA may therefore be considered as a technique of muscle training. | The XBody 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 Go USA or XBody Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBody Go USA and the XBody Pro USA may therefore be considered as a technique of muscle training. | Same |
| Portability/Mobile Use | The device is portable with ease. It is not a mobile device; its intended environment is indoors. Its intended use requires a qualified and trained operator. | The device is portable with ease. It is not a mobile device; its intended environment is indoors. Its intended use requires a qualified and trained operator. | Same |
| User interface | The device can be controlled using the graphical windows appearing on the touchscreen of the external control unit (Microsoft Surface Go 2, Microsoft Surface Go 3 or Microsoft Surface Go 4 for XBody Go USA / Microsoft Surface Pro 7, Microsoft Surface Pro 9 or Microsoft Surface Pro 10 for XBody Pro USA). On the training screen where stimulation controls can be used the START/STOP buttons are large and easily controllable. Stimulation controls for adjusting channel intensities, and all other stimulation parameters are clearly visible and easily controllable. Channel identification is supported with big pictures showing the selected muscle groups. When the stimulation is on, the STOP button is always visible and accessible. | The device can be controlled using the graphical windows appearing on the touchscreen of the external control unit (Microsoft Surface Go 2 for XBody Go USA / Microsoft Surface Pro 7 for XBody Pro USA). On the training screen where stimulation controls can be used the START/STOP buttons are large and easily controllable. Stimulation controls for adjusting channel intensities, and all other stimulation parameters are clearly visible and easily controllable. Channel identification is supported with big pictures showing the selected muscle groups. When the stimulation is on, the STOP button is always visible and accessible. | Similar. Subject devices have more options for control unit devices. The control units are equipped with the same specialized software. |
Page 9
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Menu/Settings | Easy-to-use multi-choice menu for registered and certified trainers to customize training parameters and stimulation Programs. | Easy-to-use multi-choice menu for registered and certified trainers to customize training parameters and stimulation Programs. | Same |
| Operator | To operate the devices the trainer must complete an XBody US EMS Trainer Course. The certification data received at the end of the course is required when XBody registers trainers in the device database. Only registered trainers can start training stimulation Programs using a passcode. | To operate the devices the trainer must complete an XBody US EMS Trainer Course. The certification data received at the end of the course is required when XBody registers trainers in the device database. Only registered trainers can start training stimulation Programs using a passcode. | Same |
| Display | GO: PRO: | GO: PRO: | Similar. The XBody Pro USA subject device has optional control units equipped with slightly bigger displays. |
| Statistical Functions | Training data (trainer, client, date, duration). Client related data. Number of training sessions (today, yesterday, this week, this month, total). | Training data (trainer, client, date, duration). Client related data. Number of training sessions (today, yesterday, this week, this month, total). | Same |
| Output specifications | Max Output Voltage = 20.8V @500Ω | Max Output Voltage = 20.8V @500Ω | Same |
| Max Output Current = 41.6mA @500Ω | Max Output Current = 41.6mA @500Ω | Same | |
| Max Phase Charge = 16.64µC@500Ω | Max Phase Charge = 16.64µC@500Ω | Same | |
| Max Current Density =0.65mA/cm2 @500Ω | Max Current Density =0.65mA/cm2 @500Ω | Same | |
| Max Power Density =3.46mW/cm2 @500Ω | Max Power Density =3.46mW/cm2 @500Ω | Same | |
| Net Charge (µC per pulse) | 0 @500Ω (each phase uses symmetric waveform) | 0 @500Ω (each phase uses symmetric waveform) | Same |
| Shape | Rectangular | Rectangular | Same |
Page 10
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Number of Output channels | 6 output channels, but maximum 12 independently regulated outputs in case of Training Suit (TS) 2.1 and TS 3.0. 5 output channels, but maximum 10 independently regulated outputs in case of DrySuit | 6 output channels, but 12 independently regulated outputs | Similar. The subject devices have the option to use the DrySuit which has only 10 channels. |
| Waveform | Symmetric biphasic | Symmetric biphasic | Same |
| Burst mode - Pulses per burst | 100 * 10 = 1000 | 100 * 10 = 1000 | Same |
| Burst mode - Bursts per second | 0.1 | 0.1 | Same |
| Burst mode - Burst duration (seconds) | 11 | 11 | Same |
| Burst mode - ON Time (seconds) | 10 | 10 | Same |
| Burst mode - OFF Time (seconds) | 1 | 1 | Same |
| Burst mode - Duty Cycle: Line (d)/(Line (d)+ Line (e))* | 0.91 | 0.91 | Same |
| Additional Features (specify, if applicable) | N/A | N/A | Same |
| Output frequency | 1-150Hz | 1-150Hz | Same |
| Positive pulse width | 50-500usec | 50-500usec | Same |
| Negative pulse width | 50-500usec | 50-500usec | Same |
| Power source – Battery | Li-ion 4x 3.7V (3.4 Ah) | Li-ion 4x 3.7V (3.4 Ah) | Same |
Page 11
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Size of the electrodes | Predefined electrode sizes inside the training suit described in User Manual | Predefined electrode sizes inside the training suit described in User Manual | Same |
| Safety circuits | Overload trip detects short-circuit, No-load trip detects circuit break, battery voltage monitoring, hardware error detection at startup, and watchdog monitoring. | Overload trip detects short-circuit, No-load trip detects circuit break, battery voltage monitoring, hardware error detection at startup, and watchdog monitoring. | Same |
| Plugs | The XBody Go USA and XBody Pro USA tablets and the XBody Actiwear G2 wireless stimulation unit are connected wirelessly. The XBody Actiwear G2 and the XBody Training Suit are connected with magnetic connectors. The internal cable of the training suit connects to snap fasteners in the suit to which detachable electrodes are attached via waterproof connections. | The XBody Go USA and XBody Pro USA tablets and the XBody Actiwear G2 wireless stimulation unit are connected wirelessly. The XBody Actiwear G2 and the XBody Training Suit are connected with magnetic connectors. The internal cable of the training suit connects to snap fasteners in the suit to which detachable electrodes are attached via waterproof connections. | Same |
| Lead Wires – Cables | TS2.1: PVC coated ultra-flexible LIFY 0,50 mm2 (256 x 0,05 mm) cables and LiYV 0,56 mm2 (7 x 0,32 mm) in the training suit. Cables are compliant with protected lead wire and patient cable safety requirements TS3.0: Suit cable: Ultra-flexible Microminiature & Miniature PVC Insulated Lead Wire Textile material (yarn): Polyester DS: PFA coated stainless steel filaments cored yarn (1.0mm~1.05mm) 275F*6, 316L | TS2.1: PVC coated ultra-flexible LIFY 0,50 mm2 (256 x 0,05 mm) cables and LiYV 0,56 mm2 (7 x 0,32 mm) in the training suit. Cables are compliant with protected lead wire and patient cable safety requirements TS3.0: Suit cable: Ultra-flexible Microminiature & Miniature PVC Insulated Lead Wire Textile material (yarn): Polyester | Similar. The subject devices have the option to use the DrySuit with its own lead wire |
Page 12
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Conductivity of the Electrodes | When using the TS 2.1 or TS 3.0, the client has two options: wearing an XBody cotton underwear (biocompatibility certified), or wearing the DryWear with lightweight thin undergarments that do not obstruct the connection between the electrodes and the skin on the glutes. When using the cotton underwear, the electrodes are contained in cotton covers which must be watered using normal tap water to create conductive media. The cotton textiles hold enough water to provide conductivity during the training. The electrodes are washable and can be disinfected, as described in User Manual. When using the XBody DryWear with undergarments, the electrodes of the TS2.1 or TS3.0 are fixed in the training suit with Velcro attachments, instead of cotton covers. Conductive media in this case is the DryWear. The XBody DrySuit must be worn with lightweight thin undergarments that do not obstruct the connection between the electrodes and the skin on the glutes. The XBody DrySuit transmits electrical stimulation to the surface of the skin without the use of water. | The client must wear an XBody cotton underwear (biocompatibility certified). The electrodes are contained in cotton covers which must be watered using normal tap water to create conductive media. The cotton textiles hold enough water to Provide conductivity during the training. The electrodes are washable and can be disinfected, as described in User Manual. | Similar |
| Soldering of the Printed Circuit Boards | In accordance with the ROHS directive, no lead solder material used. | In accordance with the ROHS directive, no lead solder material used. | Same |
| Placement of the electrodes | The electrodes are located at fixed positions in the training suit ensuring proper placement. | The electrodes are located at fixed positions in the training suit ensuring proper placement. | Same |
| Reusable pads | Yes | Yes | Same |
| Number of programs | XBody Go USA: 5 XBody Pro USA: 6 | XBody Go USA: 5 XBody Pro USA: 6 | Same |
| Treatment duration | 1 min to 60 min maximum | 1 min to 60 min maximum | Same |
| Environment(s) of use | Home healthcare environment, according to IEC 60601-1-11 | Home healthcare environment, according to IEC 60601-1-11 | Same |
| Pulse duration | 1-10 s | 1-10 s | Same |
Page 13
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Compliance standards | IEC 60529:1989+ A2:2013+C1:2019 IEC 60601-1:2005+ A1:2012+A2:2020 IEC 60601-1-2:2014 +A1:2020 IEC 60601-1-6:2010 +A1:2013+A2:2020 | IEC 60529:1989+ A2:2013+C1:2019 IEC 60601-1:2005+ A1:2012+A2:2020 IEC 60601-1-2:2014 +A1:2020 IEC 60601-1-6:2010 +A1:2013+A2:2020 | Same |
Page 14
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Compliance standards (continued) | IEC 60601-1-11:2015 +A1:2020 IEC 60601-2-10:2012 +A1:2016 IEC 62304:2006 +A1:2015 IEC 62366-1:2015 +A1:2020 | IEC 60601-1-11:2015 +A1:2020 IEC 60601-2-10:2012 +A1:2016 IEC 62304:2006 +A1:2015 IEC 62366-1:2015 +A1:2020 | Same |
| Compliance with 21 CFR 898? | YES | YES | Same |
| Automatic No-Load Trip | YES | YES | Same |
| Method of Line Current Isolation | N/A (battery-operated device) | N/A (battery-operated device) | Same |
| Patient leakage current – normal condition (µA) | N/A (battery-operated device) | N/A (battery-operated device) | Same |
| Patient leakage current – single fault condition (µA) | N/A (battery-operated device) | N/A (battery-operated device) | Same |
| Synchronous or alternating? | N/A (battery-operated device) | N/A (battery-operated device) | Same |
| Method of Channel Isolation | Hardware and timing | Hardware and timing | Same |
| Regulated Current or Regulated Voltage? | Regulated current and voltage | Regulated current and voltage | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| Automatic Over current Trip? Yes/no | Yes | Yes | Same |
| Patient Override Control? Yes/no | Yes | Yes | Same |
| Patient Override Control method | Disconnect suit connectors | Disconnect suit connectors | Same |
| Indicator Display | Yes | Yes | Same |
| Number of Output Modes | One output mode, but with varying stimulation frequency and duty cycle ranges | One output mode, but with varying stimulation frequency and duty cycle ranges | 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) | 9.65 X 6.9 X 0.33 (tablet) 1.96 X 1.96 X 0.98 (Actiwear G2) | Same |
| Housing Materials and Construction | Plastic | Plastic | Same |
Page 15
Table 2
Comparison of Predicate and Subject Training Suits: XBody Training Suit 2.1, XBody Training Suit 3.0 and XBody DrySuit
| Training suits | XBody Training Suit 2.1 & Training Suit 3.0 Predicate training suits for XBody Go USA and XBody Pro USA (K221200) | XBody DrySuit | Assessment |
|---|---|---|---|
| Compatible product | XBody Go USA XBody Pro USA | XBody Go USA XBody Pro USA | Same |
| Parts | Vest, pants, optional bands | Jacket, pants | Same |
| Material | TS 2.1: 75% Polyamide, 25% Polyester (Same as TS 2.0) TS 3.0: 40 % Polyamide, 30 % Acrylic, 25 % Polyester, 5 % Elastane | 75% Polyester, 15% Spandex, 15% Elastane | Similar |
| Underwear required during use | Yes. Option 1: same underwear for XBody Newave USA (K190038). Underwear serves as barrier to direct contact with the body during use Option 2: XBody DryWear worn over lightweight thin undergarments that do not obstruct the connection between the electrodes and the skin on the glutes. XBody DryWear is new to this submission. | Yes. The XBody DrySuit must be worn over lightweight thin undergarments that do not obstruct the connection between the electrodes and the skin on the glutes. The XBody DrySuit contacts the skin of the client directly. | Different |
| Number of channels | 12 | 10 | Similar, but less available channels |
| Number of electrodes | 24 pieces per suit | 20 pieces per suit | Similar, but less available electrodes |
| Weight with electrodes and cables | TS2.1: 2.7 – 3.3 kg (6 – 7.3 lbs.) TS3.0: 1.8 - 2.4 kg (4 – 5.3 lbs.) | 1 kg (2.2 lbs.) | Similar |
| Available Sizes | TS2.1: XXXS, XS, S, M, L, XL, XXL TS3.0: 2, 3, 3-L, 4, 4-L, 5, 5-W, 6, 7, 8 | XXS/2, XS/3, S/4, M/5, L/6, XL/7, XXL/8, XXXL/9 | Similar |
Page 16
| Parameter | Subject Device | Predicate Device | Assessment |
|---|---|---|---|
| Available Electrode Sizes and Shapes | TS2.1: 8 different electrode shapes TS3.0: 10 different electrode shapes | 9 different electrodes | Similar |
Table 3
Similarities of XBody Go USA and XBody Pro USA and Comparison to Predicate Control Unit Parameters
Page 17
| Parameter | XBody Go USA (Subject Device) | XBody Pro USA (Subject Device) | Comparison of Subject Devices | Subject Devices vs. Predicate Devices |
|---|---|---|---|---|
| Control Unit | Microsoft Surface | Microsoft Surface | Same | Same |
| Dimensions of Control Unit | 9.65" x 6.9" x 0.33" (245 mm x 175 mm x 8.3 mm) | 11.5" x 7.9" x 0.33" (292 mm x 201 mm x 8.5 mm) | Similar | Same |
| Wireless Stimulation Unit | XBody Actiwear G2 | XBody Actiwear G2 | Same | Same |
| Training Suit | Able to use XBody Training Suit 2.1, XBody Training Suit 3.0 and XBody DrySuit | Able to use XBody Training Suit 2.1, XBody Training Suit 3.0 and XBody DrySuit | Same | Similar. Predicate can only use XBody Training Suit 2.1 and XBody Training Suit 3.0 |
| Requirement for Underwear | XBody Cotton underwear or XBody DryWear worn over undergarments must be worn during use with XBody Training Suit 2.1 and XBody Training Suit 3.0. Undergarments must be worn with the XBody DrySuit. | XBody Cotton underwear or XBody DryWear worn over undergarments must be worn during use with XBody Training Suit 2.1 and XBody Training Suit 3.0. Undergarments must be worn with the XBody DrySuit. | Same | Similar. Predicate can only use XBody Training Suit 2.1 and XBody Training Suit 3.0 |
| Training Programs | Manual settings, Muscle Development, Endurance, Relax, Professional training programs | Manual settings, Muscle Development, Endurance, Relax, Professional, XBeat training programs | Similar | Similar |
| Professional Training Features | In person, Virtual trainer, Video editor | In person, Virtual trainer, Video editor | Same | Same |
| User Manual | Yes, content varies based on device design | Yes, content varies based on device design | Similar | Similar |
| Maximum number of Simultaneous Clients | 1-2 persons | 1-6 persons | Similar | Similar |
| Control Unit Storage | Tablet: 64 GB | Tablet: Solid-state drive: 128GB | Similar | Similar |
| Control Unit Display | 10.5-inch Tablet Screen | 12.3-inch Tablet Screen | Similar | Similar |
Page 18
| Parameter | XBody Go USA (Subject Device) | XBody Pro USA (Subject Device) | Comparison of Subject Devices | Subject Devices vs. Predicate Devices |
|---|---|---|---|---|
| Control Unit Battery Life | Up to 9 hours of typical device usage | Up to 15 hours of typical device usage | Similar | Similar |
Page 19
| Parameter | XBody Go USA (Subject Device) | XBody Pro USA (Subject Device) | Comparison of Subject Devices | Subject Devices vs. Predicate Devices |
|---|---|---|---|---|
| Control Panel Camera | 5.0MP front-facing camera with 1080p Skype HD video; 8.0MP rear-facing autofocus camera with 1080p HD video Dual Studio Mics 2W stereo speakers with Dolby® Audio | 5.0MP front-facing camera with 1080p full HD video; 8.0MP rear-facing autofocus camera with 1080p full HD video Dual far-field Studio Mics 1.6W stereo speakers | Similar | Similar |
| Wireless type | Wi-Fi: IEEE 802.11a/b/g/n/ac/ax Bluetooth Wireless 5.0 technology | Wi-Fi 6: 802.11ax compatible Bluetooth Wireless 5.0 technology | Similar | Similar |
| Weight of Control Unit | 1.2 lbs. (544 g) | 1.70 lbs. (775 g) | Similar | Similar |
The following is a comparison of the similarities of the subject and predicate devices as listed in Table 3.
Control unit: For the predicate devices, the control devices were limited to the Microsoft Surface Go 2 for the XBody Go USA and the Microsoft Surface Pro 7 for the XBody Pro USA. For the subject devices, the available control devices include the Microsoft Surface Go 2, Microsoft Surface Go 3, and Microsoft Surface Go 4 for the XBody Go USA, and the Microsoft Surface Pro 7, Microsoft Surface Pro 9, and Microsoft Surface Pro 10 for the XBody Pro USA. This change does not impact safety or performance, as the newly introduced control units operate the same software developed by XBody Hungary Kft., have similar specifications, and exhibit identical performance.
Number of clients: Using the predicate or the subject device versions of the XBody Go USA, the same number of clients can train at a time. Using the predicate or the subject device versions of the XBody Pro USA, the same number of clients can train at a time.
Assessment: The subject devices and the predicate devices are the same in terms of intended use, performance, and design. Similarities derive from the introduction of the XBody DrySuit and DryWear. The new device meets the same standards for safety as the predicate device.
| Specification | Microsoft Surface Go 2 | Microsoft Surface Go 3 | Microsoft Surface Go 4 |
|---|---|---|---|
| Execution platform | Intel® Pentium® Gold Processor 4425Y 8th Gen | Intel® Pentium® Gold Processor 6500Y 10th Gen | Intel N200 |
| CPU Cores | 2 | 2 | 4 |
| RAM | 4 GB | 4 GB | 8 GB |
| Graphics | Intel® UHD Graphics 615 | Intel® UHD Graphics 615 | Intel UHD Graphics |
| Display | 10.5", 1920 x 1280, 10-point multi-touch | 10.5", 1920 x 1280, 10-point multi-touch | 10.5", 1920 x 1280, 10-point multi-touch |
| Storage | eMMC drive: 64GB | eMMC drive: 64GB | UFS Drive: 64GB, 128GB, 256GB |
| Connections | 1 USB Type-C, HDMI over | 1 USB Type-C, HDMI over | 1 USB Type-C, HDMI over |
Page 20
| Parameter | Microsoft Surface Go 2 | Microsoft Surface Go 3 | Microsoft Surface Go 4 |
|---|---|---|---|
| Connections (continued) | docking adapter or Type-C | docking adapter or Type-C | docking adapter or Type-C |
| Wireless communication | Wi-Fi 6, BT/BLE 5 | Wi-Fi 6, BT/BLE 5 | Wi-Fi 6, BT/BLE 5.1 |
| Security | TPM 2.0, UEFI secure boot | TPM 2.0, UEFI secure boot | TPM 2.0, UEFI secure boot |
| OS support | Linux kernel supported | Linux kernel supported | Linux kernel supported |
| Construction | Handheld tablet with integrated battery | Handheld tablet with integrated battery | Handheld tablet with integrated battery |
| Specification | Microsoft Surface Pro 7 | Microsoft Surface Pro 9 | Microsoft Surface Pro 10 |
|---|---|---|---|
| Execution platform | Intel® i5-1035G4 10th Gen | Intel® i5-1245U 12th Gen | Intel Core Ultra 5 Processor 135U Intel Core Ultra 7 Processor 165U |
| CPU Cores | 4 | 4 | 12 |
| RAM | 8 GB | 8 GB | 8GB, 16GB, 32GB, 64GB |
| Graphics | Intel® Iris Plus Graphics 615 | Intel® Iris XE Graphics 615 | Intel Graphics |
| Display | 12.3", 2736 x 1824, 10-point multi-touch | 13.0", 2880 x 1920, 10-point multi-touch | 13.0", 2880 x 1920, 10-point multi-touch |
| Storage | SSD drive: 128GB | SSD drive: 256GB | SSD drive: 256GB, 512GB, 1TB |
| Connections | 1 USB Type-C, HDMI over docking adapter or Type-C | 1 USB Type-C, HDMI over docking adapter or Type-C | 2 USB Type-C, HDMI over docking adapter or Type-C |
| Wireless communication | Wi-Fi 6, BT/BLE 5 | Wi-Fi 6E, BT/BLE 5.1 | Wi-Fi 6E, BT/BLE 5.3 |
| Security | TPM 2.0, UEFI secure boot | TPM 2.0, UEFI secure boot | TPM 2.0, UEFI secure boot |
| OS support | Linux kernel supported | Linux kernel supported | Linux kernel supported |
| Construction | Handheld tablet with integrated battery | Handheld tablet with integrated battery | Handheld tablet with integrated battery |
Table 6
Standard Number and Title Used to Support XBody Go USA and XBody Pro USA Safety and Performance
| Standard Number | Applied Standards by Title |
|---|
Page 21
| Standard Number | Applied Standards by Title |
|---|---|
| ANSI/AAMI 60601-1:2005/(R)2012 and A1:2012. | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2:2014+A1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential 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 and essential performance -Collateral standard: Usability |
| IEC 60601-1-11:2015+A1:2020 | Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment 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 basic safety 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 Within a Risk Management Process (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: tests for 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 regulatory purposes |
Page 22
| Standard Number | Applied Standards by Title |
|---|---|
| FDA Guidance | Food and Drug Administration Guidance for theContent of Premarket Submissions for Software Contained in Medical Devices 2005 |
| FDA Guidance | Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered MuscleStimulator 510(k)s, June 9, 1999 |
G. Conclusion of Substantial Equivalence
Electrical safety and electromagnetic compatibility of the XBody Go USA and XBody Pro USA devices have been validated through independent testing in accordance with international standards. This testing covered the XBody Actiwear G2 main unit, the control unit, the XBody Training Suit 2.1, the XBody Training Suit 3.0 (all four used in both the subject and predicate devices), and the XBody DrySuit, which is newly included in this submission.
The subject devices and the predicate devices have the same software programming except for minor functionalities. The software of the subject devices has been updated to include a feature that allows users to select the DrySuit among the available training suits. Independent electrical and electromagnetic compatibility testing, along with performance testing of the subject devices, confirms that these software differences are aimed at enhancing the user interface without impacting safety and effectiveness.
Performance testing of the XBody DrySuit demonstrated acceptable similarity in intended use to the XBody Training Suit 2.1 and the XBody Training Suit 3.0, both of which were previously cleared for the XBody Go USA and XBody Pro USA predicate devices.
The predicate devices' sole applied part is the cotton underwear, which was required to be worn under the XBody Training Suit 2.1 and the XBody Training Suit 3.0. The subject devices have optional applied parts, cotton underwear (same as the predicates') and the XBody DryWear, both of which can be interchangeably worn under the XBody Training Suit 2.1 and the XBody Training Suit 3.0. Additionally, the newly introduced applied parts, the XBody DrySuit and DryWear must be worn with undergarments that do not obstruct the connection between the electrodes and the skin on the glutes.
The Power source of the subject and predicate devices is the same rechargeable battery, supported by bench and usability studies.
Conclusion: XBody Go USA and XBody Pro USA are substantially equivalent to their predicate devices. Any differences that exist between the subject and predicate devices do not affect safety or performance.
END OF DOCUMENT.