(87 days)
Not Found
No
The summary describes a device based on electronic muscle stimulation (EMS) technology for muscle training. There is no mention of AI, ML, or any related concepts in the intended use, device description, or the sections specifically checked for AI/ML mentions. The operation relies on pre-defined training programs and trainer input, not adaptive or learning algorithms.
No
The device is specifically designed as an addition to other sports and for training muscles, and explicitly states it is not for rehabilitation or therapeutic purposes.
No
The "Intended Use / Indications for Use" states that the device is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and is for "training muscles" and "improving or facilitating muscle performance." It does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "machine with electronic muscle stimulation based on EMS technology," indicating it is a hardware device that delivers electrical impulses.
Based on the provided information, the XBODY NEWAVE USA is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- XBODY NEWAVE USA Function: The XBODY NEWAVE USA is a machine that uses electronic muscle stimulation (EMS) to directly stimulate healthy muscles for training and performance improvement. It works externally on the body and does not involve the analysis of any biological specimens.
- Intended Use: The intended use clearly states it's for stimulating healthy muscles to improve or facilitate muscle performance, not for diagnosis, treatment, or analysis of bodily fluids or tissues.
Therefore, the XBODY NEWAVE USA falls under the category of a physical therapy or exercise device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
NGX
Device Description
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.
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
To operate the device the trainer must complete an XBody 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
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.
4
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 /
Application | XBODY NEWAVE USA | E-Fit EF-1280, Predicate
(K133225) | Assessment of
Substantial
Equivalence |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Powered Muscle
Stimulator | Yes | Yes | Same |
| Regulated | Yes | Yes | Same |
| Output specification | Max Output Voltage =
30 V @500Ω | Max Output Voltage = 36
V @500Ω | Similar |
| | Max Output Current =
60 mA @500Ω | Max Output Current = 72
mA @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, galvanically
isolated channels for each
output | 1 output channel can shift in
time to the 12 outputs
but electrical current can
be regulated individually
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 -
Battery | 12V 10Ah LiFePO4 battery
in sealed housing
The battery is housed in the
stand that contains the
device control panel. The
battery can only be charged
if disconnected from the
stand. | 12V (3.4Ah) Lead Acid | Similar |
| Size of the electrodes | Predefined electrode sizes
inside the training suit
described in User Manual | Electrodes with
pre-defined (supplied with
the device) size and
correct position. | Similar |
| User interface | The device can be controlled
using graphical windows
appearing on the touchscreen
of the device. 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 rotary encoder allows
for a quick set-up and
because of the push button
capability, the program can
be stopped immediately for
every channel. There are
large START/STOP and
POWER off buttons to begin
the program and for complet
epower shutdown. Because o
f the pictographs and fixed
electrodes in the clothing, it i
svery easy to set the
appropriate muscle groups. | Similar |
| Safety circuits | No load trip, overload trip
detects short-circuit and
circuit break, battery voltage | Short-circuit monitoring,
watchdog monitoring,
no load trip, no load trip | Same |
| | monitoring hardware error
detection at startup, and
watchdog monitoring | battery monitoring,
battery voltage
monitoring, output
current monitoring
(emergency STOP option),
option for self-test,
hardware error
monitoring | |
| Portability/Mobile
Use | The device is portable (17
lbs), but it is not a mobile
device. Its intended use
requires presence of a
qualified and trained
operator. | The device is portable with
difficulty. It is not a
mobile device. Its intended
use requires the qualified
and
trained operator. | Same |
| Material of the
enclosure | Composite | Stainless steel | Similar |
| Intended use | The XBODY NEWAVE
USA is intended to stimulate
healthy muscles in order to
improve or facilitate muscle
performance. | EF 1280 is intended to
stimulate healthy muscles
in order to improve or
facilitate muscle
performance. | Same |
| Operator | To operate the device the
trainer must complete an
XBody 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. | By manufacture
recommendations, the
only person who can
operate the device must
obtain certifications
provided by the seller.
This person must
complete the certification
prior to use on a patient. | Same |
| Menu / Settings | Easy-to-use multi-choice
menu for registered and
certified trainers to
customize training
parameters and stimulation
programs. | Simple one-level menu
system | Similar |
| Plugs | A spiral cable connects the
device control unit to the
training suit. The internal
cable of the training suit
connects to snap fasteners in
the suit to which detachable
electrodes are attached via
waterproof connections. | Cables connect to the
electrodes with snap
fastener and connect to
the machine with plastic
12pin waterproof ip68
connector. | Similar |
| Lead wires - cables | PVC coated ultra-flexible
LIFY 0,50 mm2 (256 x 0,05
mm) cables and LiYV 0,56 | SIFF 1-1.5mm2 (1x375
unique filaments) ultra
flexible - Compliant with
protected lead wire and | Similar |
| | mm2 (7 x 0,32 mm) in the
training suit.
Spiral cable with Li12Y11Y
25 x 0,14 mm2.
Cables are compliant with
protected lead wire and
patient cable safety
requirements | patient cable safety
requirements | |
| Conductivity of the
electrodes | The client has to wear an
XBody cotton underwear
(biocompatibility certified).
The electrodes are contained
in cotton covers which must
be soaked/ irrigated using
normal tap water to create
conductive media. The
cotton textiles holds enough
water to provide conductiv-
ity during the training. The
electrodes are washable and
can be disinfected, as
described in User Manual. | The subject needs to put
on an 100% hygroscopic
cotton underwear (surgery
textile, biocompatibility
certified) and these
underwear need to be
soaked/ irrigated with
normal tap water. So the
electro conductive media is
simply tap watered cotton
which is in contact with the
electrodes. The surface of
the electrode will not get
dry. In this case the pulse
transmission efficiency will
not decrease. The small
conductive pads are
washable and can be
disinfected | Same |
| Soldering of the
Printed Circuit
Boards | In accordance with the
ROHS directive, no lead
solder material used. | According to the ROHS
directive there is no lead
solder material used. | Same |
| Placement of the
electrodes | The electrodes are located at
fixed positions in the
training suit ensuring proper
placement. | Appropriately pre-placed
in specific areas according
to muscle anatomy. | Similar |
| Reusable pads | Yes | Yes | Same |
| Display | 10.4" resistive touchscreen | LCD 2x40 character LCD
display with LED backlight | Similar |
| Statistical Functions | Training data (trainer, client,
date, duration).
Number of trainings (today,
yesterday, this week, this
month, total). | Statistical functions –
counting the hours of
operation | Similar |
5
6
7
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
8
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
Recognition
Number |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| ANSI/AAMI 60601-1:2005/
(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance | 19-4 |
| IEC 60601-1-2:2007. | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance
- Collateral Standard: Electromagnetic disturbances -
Requirements and tests | 19-8 |
| IEC 60601-1-6:2010 (Third
Edition) + A1:2013 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability | 5-89 |
| IEC 60601-1-11:2015 | Medical electrical equipment -- Part 1-11: General
requirements for basic safety and essential performance
-- Collateral standard: Requirements for medical
electrical equipment and medical electrical systems
used in the home healthcare environment | 19-14 |
| IEC 60601-2-10:2007 +
AMD1 2012. | Medical electrical equipment - Part 2-10: Particular
requirements for the basic safety and essential
performance of nerve and muscle stimulators | 17-16 |
| IEC 62366:2007 + A1: 2014. | Medical devices – Application of usability engineering
to medical devices | 5-114 |
| ASTM-F1980 | Standard Guide for Accelerated Aging of Sterile
Barrier Systems for Medical Devices | 14-497 |
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing Within a Risk Management
Process. (Biocompatibility) | 2-156 |
| ISO 10993-5 | Biological evaluation of medical devices - part 5: tests
for in vitro cytotoxicity. | 2-153 |
| ISO 10993-10 | Biological evaluation of medical devices - part 10: tests
for irritation and skin sensitization. | 2-173 |
| ISTA 3E | General simulation test for unitized loads of the same
retail or institutional packaged-product | 5-112 |
| EN ISO 14971:2012. | Medical devices - Application of risk management to
medical devices | 5-40 |
9
| 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 the
Content of Premarket Submissions for Software
Contained in Medical Devices 2005 | N/A |
| FDA Guidance | Guidance for Industry, FDA Reviewers/Staff and
Compliance Guidance Document for Powered Muscle
Stimulator 510(k)s, June 9, 1999 | N/A |
| FDA Guidance for Industry
and FDA Staff: | Use of International Standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation and
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.