(200 days)
No
The summary describes a standard electrical muscle stimulation (EMS) device with software for control, but there is no mention of AI or ML capabilities for adapting stimulation, analyzing user data for personalized programs, or any other function typically associated with AI/ML in medical devices. The software is described as having a "moderate" level of concern, which is less likely for a device heavily reliant on complex AI/ML algorithms.
No.
The device's "Intended Use / Indications for Use" explicitly states that it "is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."
No
The Visionbody System is described as a device intended to stimulate healthy muscles for performance improvement, not for diagnosis of any condition. It explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."
No
The device description explicitly states the system includes hardware components: the Visionbody Box and Visionbody garments with electrodes.
Based on the provided information, the Visionbody System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for stimulating healthy muscles to improve or facilitate muscle performance. It is explicitly stated that it is not intended for use in conjunction with therapy or treatment of medical conditions.
- Mechanism of Action: The device works by delivering electrical impulses to stimulate muscle contractions, which is a physical interaction with the body, not an analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of diseases or conditions
The Visionbody System falls under the category of an electrical muscle stimulator intended for fitness and performance enhancement, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Visionbody System's 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 generated 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.
Product codes
NGX
Device Description
The Visionbody System is a wireless electrical muscle stimulation device for health and fitness applications. The main components are the Visionbody Box, the Visionbody Software and the choice of a Visionbody garment, whether a Visionbody Powersuit, Visionbody PowerPants or Visionbody Power Vest, dependent on a user's personal choice and needs. The Visionbody Box delivers a safe low to mid frequency electrical current to the electrodes in a Visionbody garment. The Visionbody uses electrical muscle stimulation (EMS) and electrical muscle activation (EMA) technologies to provide a streamlined approach to a user's fitness goals, especially regarding body composition, strength and endurance. Underlying to both these technologies are safe electrical impulses, which stimulate muscle contractions equating to muscle workouts.
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
adults only
Intended User / Care Setting
Can be operated by any adult, with or without a trainer. No special operational training is required.
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)
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
- Risk Management: Software Usability and Risk Analysis were done using worse-case . assumptions to verify user interface, safety features and satisfactory performance.
- Electrical Safety Testing IEC 60601-1:2005 + A1:2012 and EN 60601-1:2006 + A2:2013 to . demonstrate electrical safety of the device.
- Electromagnetic Compatibility IEC 60601-1-2:2015 to demonstrate the device does not . interfere or interact with surrounding electromagnetic equipment.
- Electrical Safety and Essential Performance of Nerve and Muscle Stimulators Testing IEC 60601-2-10:2016
- . Biocompatibility: Biocompatibility analysis of the patient contact materials was conducted for biosafety. The conductive cream has previously received market clearance.
- Software verification and validation testing were conducted on the Visionbody system and . documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
- Performance Testing was conducted on the Visionbody system to verify performance as per . requirements and specifications.
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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the seal for the Department of Health & Human Services - USA. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
April 5, 2024
VB Technologies AG Jorge Millan Regulatory Consultant Baarerstrasse 12 Zug, Zug 6300 Switzerland
Re: K222386
Trade/Device Name: Visionbody Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX
Dear Jorge Millan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on February 24, 2023. Specifically. FDA is updating this substantial equivalence (SE) letter due to a typo in the clearance date, which was incorrectly dated as March 10, 2023.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Heather Dean, PhD, OHT5: Office of Neurological and Physical Medicine Devices at Heather.Dean@fda.hhs.gov.
Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 10, 2023
VB Technologies AG Jorge Millan Regulatory Consultant Baarerstrasse 12 Zug, Zug 6300 Switzerland
Re: K222386
Trade/Device Name: Visionbody Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 12, 2023 Received: January 12, 2023
Dear Jorge Millan:
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
2
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 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 Ouality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K222386
Device Name VisionBody
Indications for Use (Describe)
The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed or ailing muscles and its use on such muscles is contraindicated.
The Visionbody System's 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 generated mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
| 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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4
510(K) Summary
Submitter Information
| Submitter | Visionbody® Technologies GmbH |
|---|---|
| Contact: | Jorge Millan, PhD |
| Regulatory Consultant | |
| Telephone number | (786) 416-5587 |
| jmillan@sigmabiomedical.com | |
| Date prepared: | Jan 12, 2023 |
Subject Device Name
| Trade/Proprietary Name: | VisionBody |
|---|---|
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered muscle stimulator |
| Product Code: | NGX |
| Class | II |
| Panel | Physical Medicine |
Predicate Device
| Predicate Device: | Katalyst Training System Model 1 |
|---|---|
| Sponsor | Katalyst Inc. |
| 510(K) | K190966 |
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Name: | Powered muscle stimulator |
| Product Code: | NGX |
| Class | II |
| Panel | Physical Medicine |
Reference Devices
| Reference Device 1 | FM-B2403A EMS (K213741) |
|---|---|
| Reference Device 2 | R-E1 EMS (K180956) |
5
Device Description:
The Visionbody System is a wireless electrical muscle stimulation device for health and fitness applications. The main components are the Visionbody Box, the Visionbody Software and the choice of a Visionbody garment, whether a Visionbody Powersuit, Visionbody PowerPants or Visionbody Power Vest, dependent on a user's personal choice and needs. The Visionbody Box delivers a safe low to mid frequency electrical current to the electrodes in a Visionbody garment. The Visionbody uses electrical muscle stimulation (EMS) and electrical muscle activation (EMA) technologies to provide a streamlined approach to a user's fitness goals, especially regarding body composition, strength and endurance. Underlying to both these technologies are safe electrical impulses, which stimulate muscle contractions equating to muscle workouts.
Indications for Use:
The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Visionbody System's 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 generated 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.
Non-Clinical Data:
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
- Risk Management: Software Usability and Risk Analysis were done using worse-case . assumptions to verify user interface, safety features and satisfactory performance.
6
- Electrical Safety Testing IEC 60601-1:2005 + A1:2012 and EN 60601-1:2006 + A2:2013 to . demonstrate electrical safety of the device.
- Electromagnetic Compatibility IEC 60601-1-2:2015 to demonstrate the device does not . interfere or interact with surrounding electromagnetic equipment.
- Electrical Safety and Essential Performance of Nerve and Muscle Stimulators Testing IEC 60601-2-10:2016
- . Biocompatibility: Biocompatibility analysis of the patient contact materials was conducted for biosafety. The conductive cream has previously received market clearance.
- Software verification and validation testing were conducted on the Visionbody system and . documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
- Performance Testing was conducted on the Visionbody system to verify performance as per . requirements and specifications.
Predicate Devices
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: Visionbody is comparable with and substantially equivalent to the Katalyst Training System Model 1 by Katalyst, Inc. cleared under K190966.
Technical Characteristics Comparison:
The basic and main technical features of the subject device are similar as the predicated device.
Feature Comparison:
Subject device has similar features and functionality as the predicate device as shown in the following comparison table:
7
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Manufacturer | Visionbody® Technologies
GmbH | Katalyst Inc. | N/A | |
| Device Name,Model | Visionbody® System Model 1 | Katalyst Training System Model
1 | N/A | |
| ClassificationName | Powered muscle stimulator | Powered muscle stimulator | Similar | |
| Regulatory Class | Class II | Class II | Similar | |
| Product Code | NGX | NGX | Similar | |
| RegulationNumber | 21 CFR 890.5850 | 21 CFR 890.5850 | Similar | |
| 510(K) Number | K222386 | K190966 | N/A | |
| Prescription/OTC | Prescription | OTC | Similar | |
| 21 CFR 898
Compliant? | Yes | Yes | Similar | |
| Compliance with | Yes | Yes | Similar | |
| voluntary standards | | | | |
| | IEC 60601-1 | IEC 60601-1 | | |
| | IEC 60601-1-2 | IEC 60601-1-2 | | |
| | IEC 60601-2-10 | IEC 60601-2-10 | | |
| | | | | |
| | ISO 10993-1:2018 | | | |
| | ISO 10993-5:2009 | | | |
| | ISO 10993-10:2010 | | | |
| | IEC 62366:2015 | | | |
| Indications of use | The Visionbody System is
an Over-The-Counter device
intended to stimulate healthy
muscles in order to improve
or facilitate muscle
performance. It is to be used
by adults only.
The Visionbody System is
not intended to be used in
conjunction with therapy or
treatment of medical
diseases or medical
conditions of any kind. None
of the training programs or
operational parameters are
designed to target injured or
ailing muscles and its use on
such muscles is
contraindicated. | The Katalyst Training
System is an over-the-
counter device intended to
stimulate healthy muscles in
order to improve or facilitate
muscle performance. It is to
be used byadults only.
The Katalyst Training
System is notintended to be
used in conjunction with
therapy or treatment of
medical diseases or medical
conditions of any kind. None
of its operational parameters
or training programs are
designed to target injured or
ailing muscles. Its use on
such muscles is
contraindicated. | Similar
Subject and primary
devices havesimilar
indications of use. | |
| | The Visionbody System's
electrical impulses allow the
triggering of action potentials on | The Katalyst Training
System's electrical impulses
allow the triggering of action | | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
| | motoneurons of motor nerves
(excitations). These excitations
of motoneurons are transmitted
to the muscle fibers via the
motor endplate where they
generated 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. | potentials on motoneurons of
motor nerves (excitations).
These motoneurons
excitations are transmitted to
the muscle fibers through the
motor endplate where they
generate mechanical muscle
fiber responses, which
correspond to muscle work.
Depending on the parameters
of the electrical impulses
(pulsefrequency, duration of
contraction, duration of rest,
total session duration),
different types of muscle
work can be imposed on the
stimulated muscles. | | |
| Target population | The Visionbody® System is
intended to be used by adults
only. | It is to be used by adults only. | Similar | |
| Components | Stimulation Device:
Visionbody®Box Visionbody®
Controlling AppPlus choice of either: Electrode garment for
full bodystimulation:
Visionbody®
Powersuit Electrode garment for
lower bodystimulation
only: Visionbody®
Powerpant Electrode garment for
those with limited
mobility: Visionbody®
PowerVest Common daily undergarments
recommended for Visionbody® | Impulse Pack stimulation
device Suit that consists of four
separate components:
vest, shorts, arm straps,
arm connectors Base layer which consists
of a shirt and a pair of
shorts to be worn
underneath the suit during
training Katalyst Controlling App | Different
Subject system
requires fewersuit
components to
work than primary
device | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
| Connection of the
device to electrodes | The stimulation device
(Visionbody® Box) is connected
directly to a Visionbody®
garment through a magnetic
pogo-pin / receptacle connector.
There are no externalconnection
cables. | Impulse Pack connects to the
suitthrough output cables that
terminate with proprietary
connectors. The suit contains an
embedded cable harness which
makes connection with the built-
inelectrodes. Neither the cable
harness nor the electrodes are
removable. The suit also
featuresleads with snap
connectors for connecting to the
arm electrodes. | Different
Subject device has
a proprietary
docking connector
on the Visionbody
suits | |
| Lead wires, cables and
plugs | The Visionbody® System has
cables woven in the suit.
Stimulation Box is controlled
over a secured Bluetooth
5.0 LE connection. | Katalyst's system uses visible
regular wires and connectors to
connect the electrodes with the
stimulation device. Stimulation
device controlled via wireless
Bluetooth connection | Similar | |
| Size of theelectrodes | Electrodes with predefined
size of
55.25 to 207 cm2 are supplied
with thedevice. | Electrodes with predefined
size of 27.79 to 179.04 cm2
are suppliedwith the device. | Similar | |
| Placement of the
electrodes | Appropriately pre-placed in
specific areas according to
muscle anatomy.
Electrodes are fully integrated
(sewn) into the Visionbody®
garment.
The electrodes cannot be
separated from the textile and
cannot be exchanged. | The electrode pads in the suit
areplaced according to the
position ofthe specific muscle
groups to be stimulated. | Similar | |
| Conductivity ofthe
electrodes | No undergarment between
skin and electrodes of
Visionbody Powersuit and
Powerpant garments required
No wetting of the
electrodes
necessary.
Conductivity gain through
perspirationduring training
warm-up.
Common undergarments
recommended to be used with | Electrodes of the suit must be
sprayed with water to get wet
before the usage. An
undergarmentis required to wear
under the suit. | Different
Subject supports
more type of suits.
Most of them are
dry suits and
doesn't require
wetting | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model I | Comparison | |
| | Visionbody PowerVest.
Electrodes of vest need wetting | | | |
| Power Source(s) | Rechargeable Lithium Polymer
(LiPo)battery, type Canon-LP10
or equivalent with 7.4V nominal
voltage and 900-1100 mAh
capacity. | Rechargeable Lithium Polymer
(LiPo) battery, 7.4V, 2050 mAh | Similar | |
| Charging System | Built-in 5V USB type-C
charger inside the
Visionbody® Box supplied via
type-C USB cable from an
external 5Vpower supply
Visionbody® System cannot be
switched on or used while
charging. | Built-in 5V battery charger
supplied via micro-USB
connector from an external 5V
power supply | Similar | |
| Method of line current
isolation | N/A (battery operated device). | N/A (battery operated device) | Similar | |
| Patient leakagecurrent | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| Normal condition | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| Single faultcondition | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| Number of output | One (NMES) | One (NMES) | Similar | |
| modes
Number of output
channels | 12 | 13 | Different
Subject can
stimulate fewer
muscle groups, but
it does not mean
degradation in
performancenor in
effectiveness | |
| Synchronous or
alternating? | Synchronous, but never 2
channelsactivated at the same
time. | Synchronous, but never 2
channelsactivated at the same
time. | Similar | |
| Method ofchannel
isolation | Multi-channel high voltage
analog switcher integrated
circuit. Every channel is
deactivated and in high
impedance state, except the one
currently active. | Multi-channel high voltage
analogswitches. Except during
channel activation, each channel
is always inhigh Z state. | Similar | |
| Regulatedcurrent or
regulated voltage? | Regulated current (all channels) | Regulated current (all channels) | Similar | |
| Software / firmware /
microprocessorcontrol | Yes | Yes | Similar | |
| Automatic overload
trip? | Yes | Yes | Similar | |
| Automatic no-load
trip? | Yes | Yes | Similar | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
| Automatic shutoff? | "On/Off" switch | "On/Off" switch | Similar | |
| Patient override
control? | Yes, push on the On/Off button
immediately stops the program | Yes | Similar | |
| Safety circuits | Short-circuit monitoring Watchdog monitoring No-load trip Overload trip Output current monitoring Connector connection
monitoring Battery voltage monitoring Hardware error monitoring Hardware manipulation
protection Integrity and authenticity
checkingof the binary code
during the firmware update
process | No-load trip Overload trip no more safety feature is
publiclyavailable | Similar | |
| Indicator display
on/off status? | Yes | Yes | Similar | |
| Low battery? | Yes | Yes | Similar | |
| Voltage/ Current
Level? | Yes
Displayed in form of
remainingpercentage | Yes | Similar | |
| User Interface | Graphical user interface
application designed to work
on mobile iOS devices of a
generation higher than the
iPhone 5, iPod 6 and iPad 6
and aminimum operating
system of version iOS 12X. | Katalyst App is running on
AppleiPad | Similar | |
| Display | iOS device screen | iPad screen | Similar | |
| Operator | Can be operated by any adult,
with orwithout a trainer. No
special operational training is
required. | Can be operated by any
adult, withor without a
trainer. | Similar | |
| Menu / Settings | Special GUI within the
application | Special GUI within the
application | Similar | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
| Number of
programs | Up to 8 main programs,
each with atleast one to
maximum five
subprograms, which can be
individually configured to a
user's specific needs. A user
or trainer is given access to
some or all these programs,
depending on their
Visionbody® System
model. | 9 main programs | Similar | |
| Maximum Duration
per Use
/ Timer range
(minutes) | Maximum program time: 40
minutes
Visual indication of remaining
training session time in
minutes/seconds over the
Visionbody® Software. | Maximum program: 20
minutes | Different
User can set
longer training
time inthe case of
the subject
device | |
| Portability /
Mobile Use | Portable with ease. Fully
mobile. Its intended use does
not require a qualified and
trained operator. | Portable | Similar | |
| Shape | Rectangular | Rectangular | Similar | |
| Weight | Visionbody® Box:
0.25 lb (113 g) without battery
0.35 (155 g) with battery | Impulse Pack: 0.55 lb (248 g) | Different
Subject device is
lighter than
predicate device. | |
| Dimensions | Visionbody® Box (W x H x
D):
2.83 x 0.98 x 4.45 in.
0.24 x 0.08 x 0.37 in.
/ 72 x 25 x 113 mm. | Impulse Pack:
5.8 x 3.07 in
0.49 x
0.26 in
148x78
mm
Connector 1: 65x32 mm
Connector 2: 56x32 mm | Different
Subject device is
smaller more
compact than
predicate device. | |
| Housing material and
construction | Plastic injection molding | Plastic injection molding | Similar | |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Similar | |
| Maximum output
voltage(+/- 10%) | 60 V @ 500Ω
60 V @ 2kΩ
60 V @ 10kΩ | 60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ | Different
The Visionbody®
Box operates ona
lower, hence safer
maximum output
voltage. | |
| Characteristic | New Device: Visionbody® | Predicative Device:
Katalyst Training System
Model1 | Comparison | |
| | | | This does not raise
questions regarding
safety and
effectivenessas
both devices
comply are within
the limits of IEC
60601-2-10. | |
| Maximum output | 120 mA ±10% @ 500Ω | 120 mA @ 500 Ω | Similar | |
| current(+/- 10%) | 30 mA ±10% @ 2kΩ | 50 mA @ 2 kΩ | | |
| | 6 mA ±10% @ 10kΩ | 10 mA @ 10 kΩ | | |
| Pulse width | 150 - 500 µs | 250 - 375 µs | Different | |
| | | | Both devices
support adjustable
pulse width,
however predicate
device has tighter
range | |
| Frequency | 4 - 100 HZ | 5 - 105 Hz | Similar | |
| Phase duration | 75 - 250 µs | 125 - 187.5 µs | Different
Both devices
support adjustable
phase duration,
however predicate
device has tighter
range | |
| Net charge | 0 µC @ 500 Ω | 0 µC @ 500 Ω | Similar | |
| Maximum phase
charge | 30 µC @ 500 Ω | 45 µC @ 500 Ω | Different
Predicate device
has higher
maximum phase
charge | |
| Maximum current
(rms)density | 2.17 mA/cm² @ 500 Ω | 1.15 mA/cm² @ 500Ω | Different
New device has
higher maximum
current density than
the predicate device | |
| Maximum Power
Density (using smallest
electrode conductive
surface area) | 6.52 mW/cm² @ 500Ω | 22.68 mW/cm² @ 500Ω | Different
New device has
lower maximum
power density than
the predicate device | |
| Characteristic | New Device: Visionbody® | Predicative Device: Katalyst Training System Model1 | Comparison | |
| Pulses perburst | 4 - 2000 | 4 - 420 | Different
Both devices support adjustable pulses per burst, however predicate device has tighter range | |
| Burst persecond | 0.025 - 0.5 | 0.125 | Different
New device has adjustable stimulation and relaxation time, so duty cycle varies depending on these settings | |
| Burst duration (seconds) | 1 - 20 s | 4 s | Different
Predicate device works with fixburst duration value | |
| Duty Cycle | 5-95% | 50% | Different
Subject device has adjustable stimulation and relaxation time, so duty cycle varies depending on these settings | |
| ON time (seconds) | 1 - 20s | 4 s | Different
Predicate device works with fix ON time value | |
| OFF time (seconds) | 1 - 20s | 4 s | Different
Predicate device works with fixOFF time value | |
| Characteristic | Visionbody | R-E1 EMS Stimulator | FM-B2403A EMS | Comparison |
| 510K Number | -- | K180956 | K213741 | -- |
| Frequency Range | 4-100 Hz | 1-110 Hz |