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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Visionbody system, a powered muscle stimulator. It details a comparison with a predicate device (Katalyst Training System Model 1) and two reference devices (FM-B2403A EMS and R-E1 EMS).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one might find for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly demonstrated through compliance with various safety and performance standards and by showing substantial equivalence to a legally marketed predicate device.

The "reported device performance" is primarily the device's compliance with safety standards and its functional characteristics. The comparison table directly addresses this.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Visionbody®)	Comparison to Predicate/Reference
Intended Use	Stimulate healthy muscles to improve/facilitate muscle performance; for adults only; not for therapy/medical conditions.	Same as predicate.	Similar
Classification	Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX.	Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX.	Similar
Compliance with Voluntary Standards	Compliance with relevant IEC and ISO standards for electrical safety, EMC, and biocompatibility.	Yes (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62366).	Similar to predicate (both comply with core electrical safety and EMC standards).
Software Level of Concern	Moderate (failure leads to delayed medical care).	Moderate level of concern.	Not directly compared, but implies software validation and verification successfully addressed this.
Maximum Output Voltage	Within safety limits of IEC 60601-2-10.	60 V @ 500Ω, 60 V @ 2kΩ, 60 V @ 10kΩ	Lower than predicate (Katalyst: 60 V @ 500 Ω, 100 V @ 2 kΩ, 100 V @ 10 kΩ). Deemed safe as both comply with IEC 60601-2-10 limits.
Maximum Output Current	Within safety limits of IEC 60601-2-10.	120 mA ±10% @ 500Ω, 30 mA ±10% @ 2kΩ, 6 mA ±10% @ 10kΩ	Similar to predicate @ 500Ω (Katalyst: 120 mA @ 500 Ω). Lower than predicate @ 2kΩ and 10kΩ. Deemed safe/effective.
Pulse Width	Acceptable range for muscle stimulation.	150 - 500 µs	Different from predicate (Katalyst: 250 - 375 µs). Both support adjustable pulse width, within acceptable ranges.
Frequency Range	Acceptable range for muscle stimulation.	4 - 100 Hz	Similar to predicate (Katalyst: 5 - 105 Hz) and reference devices (R-E1: 1-110 Hz, FM-B2403A: <199 Hz).
Maximum Phase Charge	Within safety limits.	30 µC @ 500 Ω	Lower than predicate (Katalyst: 45 µC @ 500 Ω). Similar to reference devices (R-E1: 22.8µC@500 Ohm, FM-B2403A: 35uC@500 Ohm). Deemed safe.
Maximum Current Density	Within safety limits.	2.17 mA/cm² @ 500 Ω	Higher than predicate (Katalyst: 1.15 mA/cm² @ 500Ω). Similar to reference device R-E1 (2.4 mA/cm²), and higher than FM-B2403A (0.5645 mA/cm²). Deemed safe as it's comparable to other cleared devices.
Maximum Power Density	Within safety limits.	6.52 mW/cm² @ 500Ω	Lower than predicate (Katalyst: 22.68 mW/cm² @ 500Ω). Deemed safe.
Safety Features	Comprehensive safety mechanisms.	Short-circuit, watchdog, no-load, overload trip, output current, connector, battery voltage, hardware error/manipulation monitoring, integrity/authenticity checking of binary code.	More detailed list than predicate (Katalyst only lists no-load trip, overload trip, no more publicly available). Implies enhanced safety.
Effectiveness	Performs comparably to predicate.	Demonstrated comparable performance.	No new questions raised regarding effectiveness due to similar intended use, functionality, operating principle, and comparable stimulation parameters to cleared devices.

Summary of the study that proves the device meets the acceptance criteria:

The study is a non-clinical product evaluation intended to demonstrate safety and effectiveness for substantial equivalence. It is primarily a comparison of technical characteristics and compliance with recognized standards rather than a traditional clinical trial or performance study with a test set of data.

2. Sample size used for the test set and the data provenance

There is no mention of a "test set" in the context of human data or any specific patient or subject data being used for device performance evaluation in this document. The evaluation is based on non-clinical testing of the device itself against established engineering and safety standards, and a comparative analysis against predicate and reference devices' technical specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As there is no human "test set" or diagnostic evaluation mentioned, there is no ground truth established by experts in that context. The "truth" here is compliance with technical specifications and safety standards.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered muscle stimulator, not an AI-powered diagnostic imaging system that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The term "standalone" typically refers to the performance of an AI algorithm independent of human input or review. While the Visionbody system has software, its purpose is to control electrical muscle stimulation, not to perform diagnostic or interpretative tasks where "standalone" performance metrics for AI would apply. The device's "standalone" performance would be its functional operation in stimulating muscles according to its programmed parameters, which was evaluated through performance testing.

The document states: "Software verification and validation testing were conducted on the Visionbody system and documentation was provided as recommended by FDA's Guidance... 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." This confirms standalone software testing was performed to ensure its functionality and safety.

7. The type of ground truth used

The ground truth used for this type of device (a powered muscle stimulator) is primarily:

Compliance with recognized international standards: Electrical safety (IEC 60601-1, IEC 60601-2-10), Electromagnetic Compatibility (IEC 60601-1-2), Biocompatibility (ISO 10993 series), and Usability/Risk Management (IEC 62366).
Manufacturer's own requirements and specifications: Performance testing verified the device against its own design requirements.
Predicate device characteristics: Similarity to a legally marketed predicate device (Katalyst Training System Model 1) serves as a benchmark for substantial equivalence in safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for model development. The software is for device control, not for learning or prediction based on data.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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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

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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

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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.

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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510(K) Summary

Submitter Information

Submitter	Visionbody® Technologies GmbH
Contact:	Jorge Millan, PhDRegulatory Consultant
Telephone number	(786) 416-5587
E-mail	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)

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Device Description:

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.

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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:

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Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
Manufacturer	Visionbody® TechnologiesGmbH	Katalyst Inc.	N/A
Device Name,Model	Visionbody® System Model 1	Katalyst Training System Model1	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 898Compliant?	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 isan Over-The-Counter deviceintended to stimulate healthymuscles in order to improveor facilitate muscleperformance. It is to be usedby adults only.The Visionbody System isnot intended to be used inconjunction with therapy ortreatment of medicaldiseases or medicalconditions of any kind. Noneof the training programs oroperational parameters aredesigned to target injured orailing muscles and its use onsuch muscles iscontraindicated.	The Katalyst TrainingSystem is an over-the-counter device intended tostimulate healthy muscles inorder to improve or facilitatemuscle performance. It is tobe used byadults only.The Katalyst TrainingSystem is notintended to beused in conjunction withtherapy or treatment ofmedical diseases or medicalconditions of any kind. Noneof its operational parametersor training programs aredesigned to target injured orailing muscles. Its use onsuch muscles iscontraindicated.	SimilarSubject and primarydevices havesimilarindications of use.
	The Visionbody System'selectrical impulses allow thetriggering of action potentials on	The Katalyst TrainingSystem's electrical impulsesallow the triggering of action
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
	motoneurons of motor nerves(excitations). These excitationsof motoneurons are transmittedto the muscle fibers via themotor endplate where theygenerated mechanical musclefiber responses that correspondto muscle work. Depending onthe parameters of the electricalimpulses (pulse frequency,duration of contraction, durationof rest, total session duration),different types of muscle workcan be imposed on thestimulated muscles.	potentials on motoneurons ofmotor nerves (excitations).These motoneuronsexcitations are transmitted tothe muscle fibers through themotor endplate where theygenerate mechanical musclefiber responses, whichcorrespond to muscle work.Depending on the parametersof the electrical impulses(pulsefrequency, duration ofcontraction, duration of rest,total session duration),different types of musclework can be imposed on thestimulated muscles.
Target population	The Visionbody® System isintended to be used by adultsonly.	It is to be used by adults only.	Similar
Components	Stimulation Device:Visionbody®Box Visionbody®Controlling AppPlus choice of either: Electrode garment forfull bodystimulation:Visionbody®Powersuit Electrode garment forlower bodystimulationonly: Visionbody®Powerpant Electrode garment forthose with limitedmobility: Visionbody®PowerVest Common daily undergarmentsrecommended for Visionbody®	Impulse Pack stimulationdevice Suit that consists of fourseparate components:vest, shorts, arm straps,arm connectors Base layer which consistsof a shirt and a pair ofshorts to be wornunderneath the suit duringtraining Katalyst Controlling App	DifferentSubject systemrequires fewersuitcomponents towork than primarydevice
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
Connection of thedevice to electrodes	The stimulation device(Visionbody® Box) is connecteddirectly to a Visionbody®garment through a magneticpogo-pin / receptacle connector.There are no externalconnectioncables.	Impulse Pack connects to thesuitthrough output cables thatterminate with proprietaryconnectors. The suit contains anembedded cable harness whichmakes connection with the built-inelectrodes. Neither the cableharness nor the electrodes areremovable. The suit alsofeaturesleads with snapconnectors for connecting to thearm electrodes.	DifferentSubject device hasa proprietarydocking connectoron the Visionbodysuits
Lead wires, cables andplugs	The Visionbody® System hascables woven in the suit.Stimulation Box is controlledover a secured Bluetooth5.0 LE connection.	Katalyst's system uses visibleregular wires and connectors toconnect the electrodes with thestimulation device. Stimulationdevice controlled via wirelessBluetooth connection	Similar
Size of theelectrodes	Electrodes with predefinedsize of55.25 to 207 cm2 are suppliedwith thedevice.	Electrodes with predefinedsize of 27.79 to 179.04 cm2are suppliedwith the device.	Similar
Placement of theelectrodes	Appropriately pre-placed inspecific areas according tomuscle anatomy.Electrodes are fully integrated(sewn) into the Visionbody®garment.The electrodes cannot beseparated from the textile andcannot be exchanged.	The electrode pads in the suitareplaced according to theposition ofthe specific musclegroups to be stimulated.	Similar
Conductivity oftheelectrodes	No undergarment betweenskin and electrodes ofVisionbody Powersuit andPowerpant garments requiredNo wetting of theelectrodesnecessary.Conductivity gain throughperspirationduring trainingwarm-up.Common undergarmentsrecommended to be used with	Electrodes of the suit must besprayed with water to get wetbefore the usage. Anundergarmentis required to wearunder the suit.	DifferentSubject supportsmore type of suits.Most of them aredry suits anddoesn't requirewetting
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel I	Comparison
	Visionbody PowerVest.Electrodes of vest need wetting
Power Source(s)	Rechargeable Lithium Polymer(LiPo)battery, type Canon-LP10or equivalent with 7.4V nominalvoltage and 900-1100 mAhcapacity.	Rechargeable Lithium Polymer(LiPo) battery, 7.4V, 2050 mAh	Similar
Charging System	Built-in 5V USB type-Ccharger inside theVisionbody® Box supplied viatype-C USB cable from anexternal 5Vpower supplyVisionbody® System cannot beswitched on or used whilecharging.	Built-in 5V battery chargersupplied via micro-USBconnector from an external 5Vpower supply	Similar
Method of line currentisolation	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
modesNumber of outputchannels	12	13	DifferentSubject canstimulate fewermuscle groups, butit does not meandegradation inperformancenor ineffectiveness
Synchronous oralternating?	Synchronous, but never 2channelsactivated at the sametime.	Synchronous, but never 2channelsactivated at the sametime.	Similar
Method ofchannelisolation	Multi-channel high voltageanalog switcher integratedcircuit. Every channel isdeactivated and in highimpedance state, except the onecurrently active.	Multi-channel high voltageanalogswitches. Except duringchannel activation, each channelis always inhigh Z state.	Similar
Regulatedcurrent orregulated voltage?	Regulated current (all channels)	Regulated current (all channels)	Similar
Software / firmware /microprocessorcontrol	Yes	Yes	Similar
Automatic overloadtrip?	Yes	Yes	Similar
Automatic no-loadtrip?	Yes	Yes	Similar
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
Automatic shutoff?	"On/Off" switch	"On/Off" switch	Similar
Patient overridecontrol?	Yes, push on the On/Off buttonimmediately stops the program	Yes	Similar
Safety circuits	Short-circuit monitoring Watchdog monitoring No-load trip Overload trip Output current monitoring Connector connectionmonitoring Battery voltage monitoring Hardware error monitoring Hardware manipulationprotection Integrity and authenticitycheckingof the binary codeduring the firmware updateprocess	No-load trip Overload trip no more safety feature ispubliclyavailable	Similar
Indicator displayon/off status?	Yes	Yes	Similar
Low battery?	Yes	Yes	Similar
Voltage/ CurrentLevel?	YesDisplayed in form ofremainingpercentage	Yes	Similar
User Interface	Graphical user interfaceapplication designed to workon mobile iOS devices of ageneration higher than theiPhone 5, iPod 6 and iPad 6and aminimum operatingsystem of version iOS 12X.	Katalyst App is running onAppleiPad	Similar
Display	iOS device screen	iPad screen	Similar
Operator	Can be operated by any adult,with orwithout a trainer. Nospecial operational training isrequired.	Can be operated by anyadult, withor without atrainer.	Similar
Menu / Settings	Special GUI within theapplication	Special GUI within theapplication	Similar
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
Number ofprograms	Up to 8 main programs,each with atleast one tomaximum fivesubprograms, which can beindividually configured to auser's specific needs. A useror trainer is given access tosome or all these programs,depending on theirVisionbody® Systemmodel.	9 main programs	Similar
Maximum Durationper Use/ Timer range(minutes)	Maximum program time: 40minutesVisual indication of remainingtraining session time inminutes/seconds over theVisionbody® Software.	Maximum program: 20minutes	DifferentUser can setlonger trainingtime inthe case ofthe subjectdevice
Portability /Mobile Use	Portable with ease. Fullymobile. Its intended use doesnot require a qualified andtrained operator.	Portable	Similar
Shape	Rectangular	Rectangular	Similar
Weight	Visionbody® Box:0.25 lb (113 g) without battery0.35 (155 g) with battery	Impulse Pack: 0.55 lb (248 g)	DifferentSubject device islighter thanpredicate device.
Dimensions	Visionbody® Box (W x H xD):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 in0.49 x0.26 in148x78mmConnector 1: 65x32 mmConnector 2: 56x32 mm	DifferentSubject device issmaller morecompact thanpredicate device.
Housing material andconstruction	Plastic injection molding	Plastic injection molding	Similar
Waveform	Symmetrical Biphasic	Symmetrical Biphasic	Similar
Maximum outputvoltage(+/- 10%)	60 V @ 500Ω60 V @ 2kΩ60 V @ 10kΩ	60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ	DifferentThe Visionbody®Box operates onalower, hence safermaximum outputvoltage.
Characteristic	New Device: Visionbody®	Predicative Device:Katalyst Training SystemModel1	Comparison
			This does not raisequestions regardingsafety andeffectivenessasboth devicescomply are withinthe limits of IEC60601-2-10.
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 devicessupport adjustablepulse width,however predicatedevice has tighterrange
Frequency	4 - 100 HZ	5 - 105 Hz	Similar
Phase duration	75 - 250 µs	125 - 187.5 µs	DifferentBoth devicessupport adjustablephase duration,however predicatedevice has tighterrange
Net charge	0 µC @ 500 Ω	0 µC @ 500 Ω	Similar
Maximum phasecharge	30 µC @ 500 Ω	45 µC @ 500 Ω	DifferentPredicate devicehas highermaximum phasecharge
Maximum current(rms)density	2.17 mA/cm² @ 500 Ω	1.15 mA/cm² @ 500Ω	DifferentNew device hashigher maximumcurrent density thanthe predicate device
Maximum PowerDensity (using smallestelectrode conductivesurface area)	6.52 mW/cm² @ 500Ω	22.68 mW/cm² @ 500Ω	DifferentNew device haslower maximumpower density thanthe predicate device
Characteristic	New Device: Visionbody®	Predicative Device: Katalyst Training System Model1	Comparison
Pulses perburst	4 - 2000	4 - 420	DifferentBoth devices support adjustable pulses per burst, however predicate device has tighter range
Burst persecond	0.025 - 0.5	0.125	DifferentNew device has adjustable stimulation and relaxation time, so duty cycle varies depending on these settings
Burst duration (seconds)	1 - 20 s	4 s	DifferentPredicate device works with fixburst duration value
Duty Cycle	5-95%	50%	DifferentSubject device has adjustable stimulation and relaxation time, so duty cycle varies depending on these settings
ON time (seconds)	1 - 20s	4 s	DifferentPredicate device works with fix ON time value
OFF time (seconds)	1 - 20s	4 s	DifferentPredicate 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	< 199 Hz	Similar range
Pulse width	150-500 us	200-380 us	50-180 us	Within range
Maximum Phase charge	30 uC@500 Ohm	22.8uC@500 Ohm	35uC@500 Ohm	Similar
Max. Current density	2.17 mA/cm2	2.4 mA/cm2	0.5645 mA/cm2	Similar

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Reference Devices

Evaluation of similarities and differences:

. Visionbody and the Katalyst Training System Model 1 have similar intended use, functionality, operating principle and similar technologies to achieve the intended use. In terms of usability both systems control the stimulation through an app that connects to the stimulus box, and perform the stimulation through a suit that sends the stimulation signals to the patient skin. Both systems have demonstrated safety features and comply to electrical safety and biocompatibility standards. Nonclinical testing to evaluate safety and effectiveness is similar for both systems.
Differences between both systems mainly consist in the configuration and number of suits/garments, . connection of devices to electrodes, ranges of stimulation, maximum output voltage, pulse width, pulse duration, program time and stimulation ranges. The difference in the number of garments and suits is not significant as this is a usability feature that has been properly verified and validated. The difference in stimulation parameters when comparing the Visionbody to the Katalyst Training System do not raise any issues of safety as the energy density of the Visionbody is lower than the Katalyst, and the ranges of stimulation are comparable to both systems have demonstrated similar electrical safety performance so no safety concerns are raised because of the difference in stimulation parameters. In terms of effectiveness the difference in stimulation parameters do not raise as the stimulation parameters that are different in the Visionbody compared to the Katalyst Training System are found similar to the reference predicate systems cleared for the US market.

Conclusion:

The subject device has similar technology characteristics and has similar intended use and functionality as the predicate and reference devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification and validation demonstrate that the Visionbody system performs comparably to and it is as safe and effective as the predicate device. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Visionbody is substantially equivalent to the predicate with regards to safety and effectiveness.

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).