Visionbody

K222386 · Vb Technologies AG · NGX · Feb 24, 2023 · Physical Medicine

Device Facts

• Record ID: K222386
• Device Name: Visionbody
• Applicant: Vb Technologies AG
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

Device Story

Wireless electrical muscle stimulation (EMS) and electrical muscle activation (EMA) system for fitness. Components: Visionbody Box (stimulation unit), mobile app, and electrode-integrated garments (Powersuit, PowerPants, PowerVest). Input: user-selected training programs via iOS app. Transformation: Box delivers low-to-mid frequency electrical impulses to garment electrodes; impulses trigger motoneuron action potentials, causing mechanical muscle fiber contraction. Output: muscle work/contractions. Used in fitness/home settings by adults (with or without trainer). Provider/user monitors session via app GUI. Benefits: improved body composition, strength, and endurance. Safety features: short-circuit/overload/no-load monitoring, hardware error protection, and emergency stop via On/Off button.

Clinical Evidence

Bench testing only. Includes risk management, software V&V, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), nerve/muscle stimulator performance (IEC 60601-2-10), and biocompatibility (ISO 10993). No clinical data presented.

Technological Characteristics

Wireless EMS device; rechargeable 7.4V LiPo battery; 12-channel output; symmetrical biphasic waveform; frequency 4-100 Hz; pulse width 150-500 µs. Materials: plastic injection molded housing, textile-integrated electrodes. Connectivity: Bluetooth 5.0 LE to iOS app. Sterilization: N/A. Software: moderate level of concern, firmware-controlled stimulation parameters.

Indications for Use

Indicated for healthy adults to improve or facilitate muscle performance via electrical muscle stimulation. Contraindicated for use on injured or ailing muscles or in conjunction with therapy/treatment of medical conditions.

Regulatory Classification

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.

Predicate Devices

• Katalyst Training System Model 1 (K190966)

Reference Devices

• FM-B2403A EMS (K213741)
• R-E1 EMS (K180956)

Submission Summary (Full Text)

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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 [e-mail].

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 ([e-mail]) or phone [phone] 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.

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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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, PhD<br>Regulatory Consultant |
| Telephone number | [phone] |
| E-mail | [e-mail] |
| 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:

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.

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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:<br>Katalyst Training System<br>Model1 | Comparison | |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Manufacturer | Visionbody® Technologies<br>GmbH | Katalyst Inc. | N/A | |
| Device Name,Model | Visionbody® System Model 1 | Katalyst Training System Model<br>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<br>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<br>an Over-The-Counter device<br>intended to stimulate healthy<br>muscles in order to improve<br>or facilitate muscle<br>performance. It is to be used<br>by adults only.<br><br>The Visionbody System is<br>not intended to be used in<br>conjunction with therapy or<br>treatment of medical<br>diseases or medical<br>conditions of any kind. None<br>of the training programs or<br>operational parameters are<br>designed to target injured or<br>ailing muscles and its use on<br>such muscles is<br>contraindicated. | The Katalyst Training<br>System is an over-the-<br>counter device intended to<br>stimulate healthy muscles in<br>order to improve or facilitate<br>muscle performance. It is to<br>be used byadults only.<br><br>The Katalyst Training<br>System is notintended to be<br>used in conjunction with<br>therapy or treatment of<br>medical diseases or medical<br>conditions of any kind. None<br>of its operational parameters<br>or training programs are<br>designed to target injured or<br>ailing muscles. Its use on<br>such muscles is<br>contraindicated. | Similar<br>Subject and primary<br>devices havesimilar<br>indications of use. | |
| | The Visionbody System's<br>electrical impulses allow the<br>triggering of action potentials on | The Katalyst Training<br>System's electrical impulses<br>allow the triggering of action | | |
| Characteristic | New Device: Visionbody® | Predicative Device:<br>Katalyst Training System<br>Model1 | Comparison | |
| | motoneurons of motor nerves<br>(excitations). These excitations<br>of motoneurons are transmitted<br>to the muscle fibers via the<br>motor endplate where they<br>generated mechanical muscle<br>fiber responses that correspond<br>to muscle work. Depending on<br>the parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction, duration<br>of rest, total session duration),<br>different types of muscle work<br>can be imposed on the<br>stimulated muscles. | potentials on motoneurons of<br>motor nerves (excitations).<br>These motoneurons<br>excitations are transmitted to<br>the muscle fibers through the<br>motor endplate where they<br>generate mechanical muscle<br>fiber responses, which<br>correspond to muscle work.<br>Depending on the parameters<br>of the electrical impulses<br>(pulsefrequency, duration of<br>contraction, duration of rest,<br>total session duration),<br>different types of muscle<br>work can be imposed on the<br>stimulated muscles. | | |
| Target population | The Visionbody® System is<br>intended to be used by adults<br>only. | It is to be used by adults only. | Similar | |
| Components | Stimulation Device:<br>Visionbody®Box Visionbody®<br>Controlling AppPlus choice of either: Electrode garment for<br>full bodystimulation:<br>Visionbody®<br>Powersuit Electrode garment for<br>lower bodystimulation<br>only: Visionbody®<br>Powerpant Electrode garment for<br>those with limited<br>mobility: Visionbody®<br>PowerVest Common daily undergarments<br>recommended for Visionbody® | Impulse Pack stimulation<br>device Suit that consists of four<br>separate components:<br>vest, shorts, arm straps,<br>arm connectors Base layer which consists<br>of a shirt and a pair of<br>shorts to be worn<br>underneath the suit during<br>training Katalyst Controlling App | Different<br>Subject system<br>requires fewersuit<br>components to<br>work than primary<br>device | |
| Characteristic | New Device: Visionbody® | Predicative Device:<br>Katalyst Training System<br>Model1 | Comparison | |
| Connection of the<br>device to electrodes | The stimulation device<br>(Visionbody® Box) is connected<br>directly to a Visionbody®<br>garment through a magnetic<br>pogo-pin / receptacle connector.<br>There are no externalconnection<br>cables. | Impulse Pack connects to the<br>suitthrough output cables that<br>terminate with proprietary<br>connectors. The suit contains an<br>embedded cable harness which<br>makes connection with the built-<br>inelectrodes. Neither the cable<br>harness nor the electrodes are<br>removable. The suit also<br>featuresleads with snap<br>connectors for connecting to the<br>arm electrodes. | Different<br>Subject device has<br>a proprietary<br>docking connector<br>on the Visionbody<br>suits | |
| Lead wires, cables and<br>plugs | The Visionbody® System has<br>cables woven in the suit.<br>Stimulation Box is controlled<br>over a secured Bluetooth<br>5.0 LE connection. | Katalyst's system uses visible<br>regular wires and connectors to<br>connect the electrodes with the<br>stimulation device. Stimulation<br>device controlled via wireless<br>Bluetooth connection | Similar | |
| Size of theelectrodes | Electrodes with predefined<br>size of<br>55.25 to 207 cm2 are supplied<br>with thedevice. | Electrodes with predefined<br>size of 27.79 to 179.04 cm2<br>are suppliedwith the device. | Similar | |
| Placement of the<br>electrodes | Appropriately pre-placed in<br>specific areas according to<br>muscle anatomy.<br><br>Electrodes are fully integrated<br>(sewn) into the Visionbody®<br>garment.<br><br>The electrodes cannot be<br>separated from the textile and<br>cannot be exchanged. | The electrode pads in the suit<br>areplaced according to the<br>position ofthe specific muscle<br>groups to be stimulated. | Similar | |
| Conductivity ofthe<br>electrodes | No undergarment between<br>skin and electrodes of<br>Visionbody Powersuit and<br>Powerpant garments required<br><br>No wetting of the<br>electrodes<br>necessary.<br><br>Conductivity gain through<br>perspirationduring training<br>warm-up.<br><br>Common undergarments<br>recommended to be used with | Electrodes of the suit must be<br>sprayed with water to get wet<br>before the usage. An<br>undergarmentis required to wear<br>under the suit. | Different<br>Subject supports<br>more type of suits.<br>Most of them are<br>dry suits and<br>doesn't require<br>wetting | |
| Characteristic | New Device: Visionbody® | Predicative Device:<br>Katalyst Training System<br>Model I | Comparison | |
| | Visionbody PowerVest.<br>Electrodes of vest need wetting | | | |
| Power Source(s) | Rechargeable Lithium Polymer<br>(LiPo)battery, type Canon-LP10<br>or equivalent with 7.4V nominal<br>voltage and 900-1100 mAh<br>capacity. | Rechargeable Lithium Polymer<br>(LiPo) battery, 7.4V, 2050 mAh | Similar | |
| Charging System | Built-in 5V USB type-C<br>charger inside the<br>Visionbody® Box supplied via<br>type-C USB cable from an<br>external 5Vpower supply<br>Visionbody® System cannot be<br>switched on or used while<br>charging. | Built-in 5V battery charger<br>supplied via micro-USB<br>connector from an external 5V<br>power supply | Similar | |
| Method of line current<br>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<br>Number of output<br>channels | 12 | 13 | Different<br>Subject can<br>stimulate fewer<br>muscle groups, but<br>it does not mean<br>degradation in<br>performancenor in<br>effectiveness | |
| Synchronous or<br>alternating? | Synchronous, but never 2<br>channelsactivated at the same<br>time. | Synchronous, but never 2<br>channelsactivated at the same<br>time. | Similar | |
| Method ofchannel<br>isolation | Multi-channel high voltage<br>analog switcher integrated<br>circuit. Every channel is<br>deactivated and in high<br>impedance state, except the one<br>currently active. | Multi-channel high voltage<br>analogswitches. Except during<br>channel activation, each channel<br>is always inhigh Z state. | Similar | |
| Regulatedcurrent or<br>regulated voltage? | Regulated current (all channels) | Regulated current (all channels) | Similar | |
| Software / firmware /<br>microprocessorcontrol | Yes | Yes | Similar | |
| Automatic overload<br>trip? | Yes | Yes | Similar | |
| Automatic no-load<br>trip? | Yes | Yes | Similar…