Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard EMS technology.

Therapeutic

No.
The 'Intended Use' section explicitly states, "The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind." and "not for rehabilitation purposes."

Diagnostic

No

Explanation: The document explicitly 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 "stimulating healthy muscles in order to improve or facilitate muscle performance," indicating its purpose is for training and muscle performance enhancement, not diagnosis of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device "generate[s] electronic muscle stimulation based on EMS technology," indicating it includes hardware components for electrical stimulation, not just software.

IVD (In Vitro Diagnostic)

Based on the provided text, the XBODY Go USA and XBODY Pro USA devices are not IVDs (In Vitro Diagnostics).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The XBODY devices use electronic muscle stimulation (EMS) to stimulate healthy muscles for training and performance improvement. They work directly on the body, not on samples taken from the body.
Intended Use: The intended use explicitly states the devices are for stimulating healthy muscles as an addition to sports and training, not for diagnosis, treatment, or rehabilitation of medical conditions.

Therefore, the function and intended use of the XBODY Go USA and XBODY Pro USA devices fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.

Product codes (comma separated list FDA assigned to the subject device)

NGX

Device Description

The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on EMS technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.

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

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.

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.

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 Pro USA devices are supported by independent testing per international standards, which included the XBody Actiwear G2 unit and XBody Training Suits 2.1 and 3.0.
Differences in the structures of the control units (i.e., stand-alone fabricated unit vs. modified commercial tablet) between the XBody subject devices and the XBody Newave USA predicate device are mainly due to improvements in design and programming of user interface which are supported by usability performance testing.
Performance testing of the Training Suit 3.0 demonstrated acceptable similarity in intended use to the Training Suit 2.0 that was cleared for the XBody Newave USA Predicate.
The Power source for the two subject devices is a rechargeable battery that is supported by bench and is similar in function and safety to the WiemsPro predicate device.
During the summative evaluation, the users evaluated the feeling of stimulation positively.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190038

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K181955

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

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

January 31, 2023

XBody Hungary Kft. % Bhoomika Joyappa Associate Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd Shrewsbury, Vermont 05738

Re: K221200

Trade/Device Name: XBody Go USA, XBody Pro USA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: January 17, 2023 Received: January 17, 2023

Dear Bhoomika Joyappa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tushar Bansal -S

for Heather Dean, PhD

Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221200

Device Name XBODY Go USA and XBODY Pro USA

Indications for Use (Describe)

The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification [510(k) Summary] K221200

A. General Information

Regulation Number:

Sponsor's Name:	XBody Hungary Kft.
Sponsor's Contact Person:	Orsolya Balog (Regulatory Compliance)
Address:	György Aladár u. 35-39 Budapest, Hungary 1125
orsolya.balog@XBodyworld.com
www.XBodyworld.com
Phone	+36308970191
Submission Contact Person:	Bhoomika Joyappa
Address:	Associate Regulatory Consultant
Medical Device Academy, Inc
bhoomika@fdaecopy.com
345 Lincoln Hill Rd,
Shrewsbury, VT 05738
Phone	+1.201-290-2613
Date Prepared:	April 4, 2022
B. Device
Trade Names of Companion Products:	XBody Go USA, XBody Pro USA
Common Name:	Powered Muscle Stimulator
Product Classification Code:	NGX
Regulatory Class:	2
Device Classification Name:	Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation Name:	Powered Muscle Stimulator

21 CFR 890.5850

1

4

Primary Predicate Device:	XBody Newave USA
Manufacturer:	XBody Hungary Kft
Predicate 510(k) Number:	K190038
Reference Device:	WiemsPro
Manufacturer:	Medical Cables, S.L.
Reference 510(K) Number:	K181955

C. Identification of Legally Marketed Primary Predicate Device and Reference Device

D. Description of the Devices

The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on EMS technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.

E. Indication for Use

The XBody Go USA and XBody Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used for only healthy not for rehabilitation purposes.

Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the XBody Go USA or XBody Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.

For both models, electrical impulses allow the triggering of action potentials on motor nerves (excitations). These excitations of motoneurons are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBody Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. Both models may therefore be considered a technique of muscle training.

F. Technological Characteristics

Compared to the primary predicate device, the XBody Pro USA are the same or similar in indication for use, intended use performance, design, dimensions, and materials as the primary predicate and reference devices meet the same standards for safety and performance as the primary predicate and reference devices.

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The differences cited in the comparison tables between subject, primary predicate and reference devices do not affect safety and performance of the subject devices when compared for equivalence to the primary predicate and reference devices. Where is not publicly available information for a comparison between the two subject devices (XBody Go USA) and on of the predicates (WiemsPro) in Table 1 and 3, this application relies on the subject devices to XBody Newave USA. This is noted where appropriate as "No information publicly available."

Comment on WiemsPro. This reference device is used for its wireless attributes for comparison to XBody subject devices.

Table 1
Comparison of Subject Devices (XBody Go USA and XBody Pro USA) to Predicate and Reference Devices:
General and Electrical Parameters
Parameter /
application	Subject Device
XBody Go USA
and
XBody Pro USA
(K221200)	Primary Predicate
XBODY Newave USA
(K190038)	Reference Device
WiemsPro
(K181955)	Assessment of Substantial Equivalence
				XB Go USA & XB Pro USA vs.
XB Newave USA	XB Go USA & XB Pro USA
vs. WiemsPro

Powered Muscle
Stimulator	Yes	Yes	Yes	Same	Same
Regulated voltage	Yes	Yes	Yes	Same	Same
Intended 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	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.	WiemsPro is intended to
stimulate healthy muscles
in order to
improve or facilitate
muscle performance. The
WiemsPro is not intended
to be used in conjunction
with therapy or treatment
of medical diseases or
medical conditions of any
kind. None of WiemsPro
training programs is
designed for injured or
ailing muscles and its use
on such muscles	Same	Same

6

| (clients), not for
rehabilitation
purposes. | 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 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 | is contraindicated.

WiemsPro is a machine
with electronic muscle
stimulation based on EMS
technology.
Regarding its use, 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.

WiemsPro electrical
impulses allow the
triggering of action
potentials on
motoneurones of motor
nerves (excitations).
These excitations of
motoneurones 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), | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|--|--|--|
| 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 | 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. | work
can be imposed on the
stimulated muscles. | | | muscle training. | | | | |
| 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 (17
lbs.), but it is not a mobile
device. Its intended use
requires the presence of a
qualified and trained
operator. | No information publicly
available | Similar. Both the primary
predicate device and the subject
devices are portable. | N/A | | | | |
| Go out Mode | Present | Not available | No information publicly
available | This is an additional upgrade to the
device's functionality. The impact
of the Go out mode on safety and
effectiveness was evaluated
through risk management. In Go
out mode, you have a lot of
freedom and flexibility to
customize your training, so it is an
exceptionally useful feature. With
the issued risk control measures,
safety of the Go out mode is
ensured. Users are provided with
comprehensive information in user
manuals for the device before
using it during training, reducing
the risk of accidents | N/A | | | | |
| User interface | The device can be
controlled using the
graphical windows
appearing on the
touchscreen of the
external control unit
(Microsoft Surface | The device can be
controlled using the
graphical windows
appearing on the
touchscreen of the device.
On the training screen
where stimulation | No information publicly
available | Similar. Both the primary
predicate device and the subject
devices utilize a device with
touchscreen as control unit. | N/A | | | | |

7

8

9

| 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. | 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. | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 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
stimulationPrograms. | No information publicly
available | Same | N/A | |
| Operator | To operate the | To operate the device the | No information publicly | Same | N/A | |
| | devices the trainer
must complete an
XBody US EMS | trainer must complete an
XBody US EMS Trainer
Course. The certification | available | | | |
| | Trainer Course. The
certification data | data received at the end of
the course is required | | | | |
| | received at the end
of the course is | when XBody registers
trainers in the device | | | | |
| | required when
XBody registers | database. Only registered
trainers can start training | | | | |
| | trainers in the device
database. Only | stimulation Programs
using a passcode. | | | | |
| | registered trainers
can start training | | | | | |
| | stimulation
Programs using a | | | | | |
| | passcode. | | | | | |
| Display | GO:
PRO: | 10.4" resistive
touchscreen | No information publicly
available | Different. Subject devices have
bigger screens with capacitive
LCD touch screens providing
more accurate touch reading | Similar | |
| Statistical
Functions | Training data
(trainer, client,date,
duration). Client
related data.
Number of training
sessions (today, | Training data (trainer,
client,date, duration).
Client related data.
Number of training
sessions (today,yesterday,
this week, this month,
total). | No information publicly
available | Same | N/A | |
| | yesterday, this week,
this month, total). | | | | | |
| Output
specifications | Max Output Voltage | Max Output Voltage =
20.8V @500 $\Omega$ | Max Output Voltage =
30V @500 $\Omega$ | Max Output Voltage
= 62.5V @500 $\Omega$ | Similar. Subject devices have
lower max output voltage.
This particular feature has
already been tested to IEC | Different. Subject devices have
lower max output voltage.
This particular feature has
already been tested to IEC |

10

11

| Max Output Current | Max Output Current =60
mA @500Ω | Max Output Current
= 125mA @500Ω | 60601-1:2005+ A1:2012+
A2:2020. This difference does
not raise any concern for safety
and effectiveness.
Similar. Subject devices have
lower max output current. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | 60601-1:2005+ A1:2012+
A2:2020. This difference does
not raise any concern for safety
and effectiveness.
Different. Subject devices have
lower max output current. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max Phase Charge
= 16.64μC@500Ω | Max Phase Charge
= 24μC@500Ω | No information publicly
available | Similar. Subject devices have
lower max phase charge. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | N/A | |
| Max Current
Density =
0.65mA/cm2
@500Ω | Max Current Density =
0.61mA/cm2 @500Ω | Max Current Density
=1.92mA/cm2 @500Ω | Similar. Subject devices have
lower max current density. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | Different. Subject devices have
lower max current density. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | |
| Max Power Density
=3.46mW/cm2
@500Ω | Max Power Density =
7.27mW/cm2 @500Ω | Max Power Density =
9.61mW/cm2 @500Ω | Similar. Subject devices have
lower max power density. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | Different. Subject devices have
lower max power density. This
particular feature has already
been tested to IEC 60601-
1:2005+ A1:2012+ A2:2020.
This difference does not raise
any concern for safety and
effectiveness. | |
| | | | | effectiveness. | effectiveness. |
| Net Charge (µC
per pulse) | 0 @500Ω
(each phase uses
symmetric
waveform) | 0 @500Ω
(each phase uses
symmetric waveform) | Information Not
Available | Same | N/A |
| Shape | Rectangular | Rectangular | Rectangular | Same | Same |
| Number of Output
channels | 6 output channels,
but 12
independently
regulated outputs | 10 individual,
galvanically isolated
channels for each output | l output channel can
shift intime to 10 outputs,
but electrical current can
be regulated individually
on every output | Similar | Different. Subject devices have
more independently regulated
output channels. |
| Waveform | Symmetric biphasic | Symmetric biphasic | Symmetric biphasic | Same | Same |
| Burst mode -
Pulses per burst | 100 * 10 = 1000 | 100 * 10 = 1000 | Information Not
Available | Same | N/A |
| Burst mode -
Bursts per second | 0.1 | 0.1 | Information Not
Available | Same | N/A |
| Burst mode - Burst
duration (seconds) | 11 | 11 | Information Not
Available | Same | N/A |
| Burst mode - ON
Time (seconds) | 10 | 10 | Information Not
Available | Same | N/A |
| Burst mode - OFF
Time (seconds) | 1 | 1 | Information Not
Available | Same | N/A |
| Burst mode - Duty
Cycle:
Line (d)/(Line (d)+
Line (e))* | 0.91 | 0.91 | Information Not
Available | Same | N/A |
| Additional
Features (specify,
if applicable) | N/A | N/A | N/A | N/A | N/A |
| Output frequency | 1-150Hz | 1-100Hz | 1-100Hz | Different. Object devices provide
better customization through a
wider spectrum of output | Different. Object devices provide
better customization through a
wider spectrum of output |
| Positive pulse width | 50-500usec | 50-400usec | 100-400usec | frequency.
During the summative evaluation, the users evaluated the feeling of stimulation positively.
The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. Therefore, the difference would not affect safety and effectiveness of the subject device. | frequency.
During the summative evaluation, the users evaluated the feeling of stimulation positively.
The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. Therefore, the difference would not affect safety and effectiveness of the subject device. |
| | | | | Different. Object devices provide better customization through a wider spectrum of positive pulse width.
During the summative evaluation, the users evaluated the feeling of stimulation positively.
The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+ A2:2020. Therefore, the difference would not affect safety and effectiveness of the subject device. | Different. Object devices provide better customization through a wider spectrum of positive pulse width.
During the summative evaluation, the users evaluated the feeling of stimulation positively.
The main output parameters (output current and output voltage) are lower for the subject devices than for the primary predicate and reference device. This particular feature has already been tested to IEC 60601-1:2005+ A1:2012+ A2:2020. Therefore, the difference would not affect safety and effectiveness of the subject device. |
| Negative pulse
width | 50-500usec | 50-400usec | 100-400usec | Different. Object devices provide
better customization through a
wider spectrum of negative pulse
width.
During the summative evaluation,
the users evaluated the feeling of
stimulation positively.
The main output parameters
(output current and output voltage) are lower for the subject devices
than for the primary predicate and
reference device. This particular
feature has already been tested to
IEC 60601-1:2005+ A1:2012+
A2:2020. Therefore, the difference
would not affect safety and
effectiveness of the subject device. | Different. Object devices provide
better customization through a
wider spectrum of negative pulse
width.
During the summative
evaluation, the users evaluated
the feeling of stimulation
positively.
The main output parameters
(output current and output
voltage) are lower for the subject
devices than for the primary
predicate and reference device.
This particular feature has
already been tested to IEC
60601-1:2005+ A1:2012+
A2:2020. Therefore, the
difference would not affect safety
and effectiveness of the subject
device. |
| Power source –
Battery | Li-ion 4x 3.7V (3.4
Ah) | 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. | LiPo 3.7V (2.4Ah) | Similar. Both the predicate and
subject devices use rechargeable
batteries. For the subject device, a
Li-ion battery was selected due to
its light weight and compatibility
with the compact design. | Similar |
| 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 | No information publicly
available | Similar | N/A |
| Safety circuits | | | | | |
| | Overload trip
detects short-circuit, | Overload trip detects
short-circuit, No-load trip | Software/Firmware/Micro processor Control: Yes | Same | Different, subject devices
utilize a wider range of safety
features |
| | No-load trip detects
circuit break, battery | detects circuit break,
battery voltage | Automatic Overload Trip:
Yes | | |
| | voltage monitoring, | monitoring, hardware | Automatic Shut Off:
On/Off switch | | |
| | hardware error
detection at startup, | error detection at startup,
and watchdog | Patient Override Control:
Yes, push on On/Off
button directly pause the
program | | |
| | and watchdog
monitoring. | monitoring. | | | |
| 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. | 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. | No information publicly
available | Different. Primary predicate has
built-in control panel, while the
subject device connects
wirelessly with the control unit.
The subject devices are worn by
the client, therefore no spiral
cable is needed to connect with
the training suit. | N/A |
| Lead Wires -
Cables | TS2.1: PVC coated
ultra-flexible LIFY
0,50 mm2 (256 x
0,05 mm) cables and
LiYY 0,56mm2 (7 x | PVC coated ultra-flexible
LIFY 0,50 mm2 (256 x
0,05 mm) cables and
LiYV 0,56mm2 (7 x 0,32
mm) in the training suit. | No information publicly
available | Similar. The subject devices are
worn by the client, therefore no
spiral cable is needed to connect
with the training suit. The wires
in the predicate device and TS | N/A |
| | 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 | Spiral cable with
Li12Y11Y25 x 0,14
mm2. Cables are
compliant with protected
lead wire and patient
cable safety requirements | | 2.1 are the same.
The wires in the predicate and
the TS 3.0 are similar to
eachother. | |
| Conductivity of the
Electrodes | 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. | 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. | No information publicly
available | Same | N/A |
| Soldering of the
Printed Circuit
Boards | In accordance with
the ROHS directive,
no leadsolder
material used. | In accordance with the
ROHS directive, no lead
solder material used. | No information publicly
available | Same | N/A |
| 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. | No information publicly
available | Same | N/A |
| Reusable pads | Yes | Yes | Yes | Same | Same |
| Number of
programs | XBody Go USA: 5
XBody Pro USA: 6 | 4+10 | 20 | Same to Go USA;
Similar to Pro USA | Different
XBody devices has a manual
program that provides a broader
range of stimulation parameters
which ensures a more customized
training experience compared to
the 20 training programs with
fixed stimulation parameters of the
Wiemspro. |
| Treatment
duration | 1 min to 60 min
maximum | 1 min to 60 min maximum | No information publicly
available | Same | The treatment duration is
identical to the primary predicate
device. |
| Environment(s) of
use | Home healthcare
environment,
according to IEC
60601-1-11 | Home healthcare
environment, according to
IEC 60601-1-11 | No information publicly
available | Same | The environment of use is
identical to the primary predicate
device. |
| Pulse duration | 1-10 s | 1-10 s | No information publicly
available | Same | The pulse duration is identical to
the primary predicate device. |
| 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 60601-1-
11:2015 +A1:2020
IEC 60601-2- | IEC 60601-1:2005 + C1 +
C2 + A1,
IEC 60601-1-2:2014,
IEC 60601-1-6:2010 +
A1:2013,
IEC 60601-1-11:2015,
IEC 60601-2-10:2012 +
A1:2016,
IEC 62366:2007 +
A1:2014 | IEC 60601-1-2:2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006
ISO 14971:2007
ANSI/AAMI ES60601-
1:2005 / A2:2010 | Since the predicate device is a
wired device, wireless Coexistence
QoS and Coexistence testing was
not required. Due to the subject
device's wi-fi capability, it was
also tested for additional
standards, such as ANSI/AAMI
TIR 69:2017, IEEE/ANSI C63.27-
2017 and ANSI/AAMI
TIR57:2016. The standards are
FDA-recognized and align with | Due to the subject device's wi-fi
capability, it was also tested for
additional standards, such as
ANSI/AAMI TIR 69:2017,
IEEE/ANSI C63.27-2017 and
ANSI/AAMI TIR57:2016. The
standards are FDA-recognized
and align with the Guidance
Document "Radio Frequency
Wireless Technology in Medical
Devices". This ensures the |
| | IEC 62304:2006
+A1:2015
IEC 62366-1:2015
+A1:2020
ANSI/AAMI TIR
69:2017
IEEE/ANSI C63.27-
2017
ANSI/AAMI TIR
57:2016 | | | Frequency Wireless Technology in device's overall safety and
Medical Devices". This ensures
the device's overall safety and
effectiveness. | effectiveness. |
| Automatic No-
Load Trip | YES | YES | YES | Same | 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 | One output mode, but
with varying stimulation
frequency and duty cycle
ranges | Same | Same |
| Total Dimensions
(in.) [W x H x D] | 9.65 X 6.9 X 0.33
(tablet)
1.96 X 1.96 X 0.98
(Actiwear G2) | 15.74 X 18.11 X 10.63 | 6.66 X 3.27 X 1.18 | Different, subject devices are
smaller for a more compact
design. | Different, subject devices are
smaller for a more compact
design. |
| Housing Materials
and Construction | Plastic | Composite | Plastic | Different, subject devices have
plastic housing. As a result of its
durability, heat resistance, and
low maintenance requirements,
plastic was chosen as the housing
for the subject device. | Same |
| Footnote: In Table 1, N/A (not available) means that the comparison cannot be made to one of the predicate devices because information is not publicly available. | | | | | |

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13

14

15

16

17

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

19

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

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

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

20

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

| Table 3

Similarities of XBody Go USA and XBody Pro USA and Comparison to Primary Predicate Control Panel Parameters
Parameter	XBody Go USA
(Subject Device)	XBody Pro USA
(Subject Device)	Comparison of
Subject Devices	Subject Devices vs.
XBody Newave USA
Control Unit	Microsoft Surface	Microsoft Surface	Same	Similar, built for XB
Newave
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	Different, predicate
not a tablet
Wireless
Stimulation Unit	XBody Actiwear G2	XBody Actiwear G2	Same	Similar, but predicate
not wireless
Training Suit	Able to use XBody Training Suit 2.1 or
XBody Training Suit
3.0	Able to use XBody Training Suit 2.1 or
XBody Training Suit 3.0	Same	Different, predicate
uses TS2.0
Requirement for
Underwear	XBody Underwear must be worn during
use.	XBody Underwear must be worn during
use.	Same	Same
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	Similar
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, 1 person for
the predicate
Control Panel
Storage	Tablet: 64 GB	Tablet: Solid-state drive: 128GB	Similar	Different: Box
Control Panel
Display	10.5-inch Tablet Screen	12.3-inch Tablet Screen	Similar	Similar
Control Panel
Battery Life	Up to 9 hours of typical device usage	Up to 15 hours of typical device usage	Similar	Different, predicate
has Mains Power
Source
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	Different: No Camera
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	N/A
Weight of Control
Unit	1.2 lbs. (544 g)	1.70 lbs. (775 g)	Similar	Different, uses a stand

21

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

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

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

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

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

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

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

22

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

| Table 4
Standard Number and Title Used to Support

XBody Go USA and XBody Pro USA Safety and Performance
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
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

23

G. Conclusion of Substantial Equivalence

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

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

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

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

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

24

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

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

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

END OF DOCUMENT.