FastFit EMS System

K192161 · Fast Fit, LLC · NGX · Jan 22, 2020 · Physical Medicine

Device Facts

• Record ID: K192161
• Device Name: FastFit EMS System
• Applicant: Fast Fit, LLC
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The FastFit EMS System is Rx only.

Device Story

FastFit EMS System is a wearable compression suit with embedded electrodes for electrical muscle stimulation (EMS) during exercise. System components include a Nylon/Spandex suit, EMS controller, power adapter, and smartphone software application. User controls stimulation intensity and target locations via Bluetooth-connected smartphone app; parameters upload to the controller. Controller delivers symmetrical biphasic pulses to major muscle groups. Device is intended for healthy individuals to improve muscle performance; not for medical treatment. Benefits include muscle conditioning during physical activity. Healthcare providers prescribe the device; users operate it independently. Output is localized electrical stimulation; users monitor intensity and duration via the app interface. Safety features include automatic overload trip, automatic shutoff, and physical emergency stop button.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including system design verification, software validation, electrical safety (IEC 60601-1 series), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, -5, -10), and usability/human factors testing.

Technological Characteristics

Wearable compression suit (Nylon/Spandex/Polyester) with embedded conductive fabric electrodes. Powered by 3.7V LiPo battery. Connectivity via Bluetooth Smart (BT LE 4.0). Waveform: Symmetrical biphasic, rectangular. Frequency: 84 Hz. Pulse width: 300 µs. 10 output channels. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-10, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for healthy adults to stimulate muscles to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles or as adjunctive therapy for 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

• Compex® Wireless USA (K143551)
• Katalyst Mark 1 Muscle Stimulation System (K181199)

Submission Summary (Full Text)

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January 22, 2020

Fast Fit LLC % Sigi Caron Regulatory Consultant Biologics and Medical Device Consulting Group 20370 Skyhawk Lane Topanga, CA 90290

Re: K192161

Trade/Device Name: FastFit EMS System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 24, 2019 Received: October 24, 2019

Dear Sigi Caron:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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.

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192161

Device Name FastFit EMS System

#### Indications for Use (Describe)

The FastFit EMS System is intended to simulate healthy muscles in order to improve or facilitate muscle performance.

It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The FastFit EMS System is Rx only.

Type of Use (Select one or both, as applicable)

|--|--|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 1. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| DATE PREPARED | August 6, 2019 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | Fast Fit LLC<br>450 Park Avenue<br>31st Floor<br>New York, NY 10022 |
| OFFICIAL<br>CORRESPONDENT | Sigi Caron, MBA RAC<br>Biologics and Medical Device Consulting Group<br>20370 Skyhawk Lane<br>Topanga, CA 90290<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| TRADE NAME | FastFit EMS System |
| COMMON NAME | Stimulator, Muscle Powered, for Muscle Conditioning |
| DEVICE CLASSIFICATION | Name: Powered Muscle Stimulator<br>Regulation No: 21 CFR §890.5850<br>Product Code: NGX - Stimulator, Muscle Powered, for<br>Muscle Conditioning<br>Class: II |
| PREDICATE DEVICE | Compex® Wireless USA (K143551)<br>Katalyst Mark 1 Muscle Stimulation System (K181199) |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components:

- FastFit Exercise Suit
- EMS Controller
- Power Adaptor
- FastFit Software Application

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The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals.

EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.

## INDICATIONS FOR USE:

The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The FastFit EMS System is Rx only.

## SUBSTANTIALLY EQUIVALENT TO:

The FastFit EMS System is substantially equivalent in intended use and technological features to two other commercially available powered muscle stimulator systems:

- . Compex® Wireless USA (K143551)
- . Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199)

### BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The FastFit EMS system is substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The following table compares the features of the proposed device and its predicates.

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| Element | New Device:<br>FastFit EMS System | Primary Predicate:<br>Compex Wireless USA | Secondary Predicate:<br>Katalyst Mark 1 Muscle<br>Stimulation System Model 2 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | --- | K143551 | K181199 |
| Indications for Use | The FastFit EMS system "is<br>intended to stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance.<br>It is not intended to be used<br>in conjunction with therapy<br>or treatment of medical<br>diseases or medical<br>conditions of any kind."<br>None of the stimulation<br>programs or operational<br>parameters are designed to<br>target injured or ailing<br>muscles and its use on such<br>muscles is contraindicated."<br>The FastFit EMS system is<br>Rx only. | The Compex Wireless USA<br>is an Over-The-Counter<br>device "intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance." It is to be<br>used by adults only. The<br>Compex Wireless USA is<br>"not intended for<br>adjunctive therapy in the<br>treatment of medical<br>diseases and conditions of<br>any kind." None of the<br>Compex Wireless USA<br>stimulation programs are<br>designed for injured or<br>disease afflicted muscles. Its<br>use on such muscles is<br>contraindicated. The work<br>imposed on the muscles by<br>the Compex Wireless USA<br>electrical impulses allow the<br>triggering of action<br>potentials of motoneurones<br>are transmitted to the<br>muscle fibers via the motor<br>endplate where they<br>generate mechanical muscle<br>fiber responses that<br>correspond to muscle work.<br>Depending on the<br>parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration, different<br>types of muscle work can be<br>imposed on the simulated<br>muscles.<br>The Compex Wireless USA<br>may therefore be considered<br>a technique of muscle<br>training. | The Katalyst Mark 1 "is<br>intended to stimulate healthy<br>muscles in order to improve<br>or facilitate muscle<br>performance.<br>It is not intended to be used<br>in conjunction with therapy<br>or treatment of medical<br>diseases or medical<br>conditions of any kind."<br>None of the training programs<br>or operational parameters are<br>designed to target injured or<br>ailing muscles and its use on<br>such muscles is<br>contraindicated."<br>The Katalyst Mark 1 is Rx<br>only. |

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| Element | New Device:<br>FastFit EMS System | Primary Predicate:<br>Compex Wireless USA | Secondary Predicate:<br>Katalyst Mark 1 Muscle<br>Stimulation System Model 2 |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | | Device Features | |
| Connection of device to<br>electrodes | The EMS controller is<br>connected via a cable<br>electrode harness directly to<br>the electrode pads. | Stimulation Module is<br>directly connected to the<br>custom Compex female<br>SNAP assembled in the<br>electrode. | The Katalyst Impulse Pack<br>unit is connected via a cable<br>electrode harness directly to<br>the electrodes. |
| Power Source | EMS Controller Module:<br>Rechargeable 3.7[V] / ≥<br>1800[mAh] LiPo battery | Remote: : Rechargeable<br>3.7[V] / ≥ 1500[mAh] LiPo<br>battery<br>Stimulation Modules:<br>Rechargeable 3.7[V] / ≥<br>450[mAh] LiPo battery | Li-Po rechargeable battery<br>3.8V, 7.79Wh<br>(2050mAh) |
| Charging System | AC/DC 5[v] 2.0 [A];<br>Distributed through docking<br>station | AC/DC 5[v] 3.5[A];<br>Distributed through docking<br>station to remote and 4<br>modules | AC/DC wall plug in,<br>distributed directly to the<br>device. 18.0[v], 1.33[A] |
| Method of line current<br>isolation | N/A (battery operated<br>device) | N/A (battery operated<br>device) | N/A (battery operated device) |
| Patient Leakage<br>Current<br>-Normal Condition<br>-Single Fault<br>Condition | N/A (battery operated<br>device) | N/A (battery operated<br>device) | N/A (battery operated device) |
| Number of Output<br>Modes | One (NMES) | One (NMES) | One |
| Number of Output<br>Channels<br>-Synchronous or<br>alternating? | 10<br>alternating<br>(never 2 channels activated<br>at the same time) | 4<br>Synchronous, but never 2<br>channels activated at the<br>same time | 10<br>Not publicly available |
| Method of Channel<br>Isolation | Each channel is the middle<br>of a H-Bridge. Except when<br>it is activated, each channel<br>is always in high impedance<br>state. | Each channel is the middle<br>of a H-Bridge. Except when<br>it is activated, each channel<br>is always in high impedance<br>state. | Not publicly available |
| Regulated Current or<br>Regulated Voltage? | Regulated current (all<br>channels) | Regulated current (all<br>channels) | Not publicly available |
| Electrode Integrated<br>into a body suit? | Yes | No. Placement of electrodes<br>is dictated by the operator. | Yes |
| Number of Electrodes | 2 per channel,<br>4 per channel on each arm<br>and on each leg;<br>Max 20 | Not publicly available | Only 2 per channel; Max 20 |

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| Element | New Device:<br>FastFit EMS System | Primary Predicate:<br>Compex Wireless USA | Secondary Predicate:<br>Katalyst Mark 1 Muscle<br>Stimulation System Model 2 |
|-----------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Electrode Leads<br>Compliant with 21 CFR<br>898? | Yes | Yes | Yes |
| Electrode Interface | 10mm magnetic buttons | Not publicly available | 4mm Standard SNAP<br>Connector |
| Wireless<br>Communication with<br>Control Interface | Yes. Uses Bluetooth Smart<br>(BT LE 4.0) | Not publicly available | Yes. Uses Bluetooth Smart<br>(BT LE 4.0) |
| Mobile / Form Factor | Yes (smartphone, stim<br>device attached to suit, and<br>wearable suit) | Not publicly available | Portable with difficulty, no<br>mobile device, its intended<br>use requires a Katalyst<br>certified operator. |
| Channel Control<br>Interface | Touch user interface<br>provided by FastFit<br>application on smartphone. | Not publicly available | Using rotary encoder knobs<br>for each channel and master<br>rotary encoder for all<br>channels |
| Instant Shutoff | Physical Button | Not publicly available | Physical Button |
| Software / Firmware /<br>Microprocessor<br>Control? | Yes | Yes | Yes |
| Automatic Overload<br>Trip? | Yes | Yes | Yes |
| Automatic No-Load<br>Trip? | No | Yes | No |
| Automatic Shutoff? | Yes | Yes | Yes |
| Patient Override<br>Control? | Yes | Yes | No |
| Interface Indicator<br>Display:<br>-On/Off Status | Yes (on remote and module<br>units) | Yes | Yes (on Impulse Pack via<br>LED and in application) |
| -Low Battery | Yes | Yes | Yes (on Impulse Pack) |
| -Voltage/Current<br>Level | Yes (on smartphone) | Yes | Yes (in application) |
| -Charging | Yes | Yes | Yes (on Impulse Pack) |
| -Duration of training | Yes (on smartphone) | Yes | Yes (in application) |
| Timer Range in Minutes | Maximum = 120 minutes | Maximum = 48 minutes | Maximum = 20 minutes |
| Weight | Controller Module: 505 g<br>EMS Suit: 695 g | Remote: 119 g<br>Stimulation Module: 2x60 g<br>Docking Station: 800 grams | Not publicly available |

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| Element | New Device:<br>FastFit EMS System | Primary Predicate:<br>Compex Wireless USA | Secondary Predicate:<br>Katalyst Mark 1 Muscle<br>Stimulation System Model 2 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Dimensions | Controller Module:<br>11.7x8.9x4.8 cm | Remote: 9x4.5x0.7 cm<br>Stimulation Module: 6.5x2<br>cm<br>Docking Station: 25x25x2<br>cm | Not publicly available |
| Housing Materials and<br>Construction | Nylon, Spandex<br>Polyester w/ Conductive<br>Coating | Not publicly available | Not publicly available |
| | | Output Specifications | |
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic |
| Shape | Rectangular | Rectangular | Rectangular |
| Maximum Output<br>Voltage (±10%) | 35 V @500 Ω<br>95 V @ 2 kΩ<br>96 V @ 10 kΩ | 60 V @ 500 Ω<br>180 V @ 2 kΩ<br>180 V @ 10 kΩ | 60 V @ 500 Ω<br>96 V @ 2 kΩ<br>114.2 V @ 10 kΩ |
| Maximum Output<br>Current (±10%) | 70 mA @500 Ω<br>47.5 mA @ 2 kΩ<br>9.6 mA @ 10 kΩ | 120 mA @ 500 Ω<br>90 mA @ 2 kΩ<br>18 mA @ 10 kΩ | 120 mA @ 500 Ω<br>48 mA @ 2 kΩ<br>11 mA @ 10 kΩ |
| Pulse Width | 300 µs | 300 to 400 µs | 175 µs |
| Frequency | 84 Hz | 1 to 120 Hz | 85 Hz |
| For multiphasic<br>waveforms only:<br>-Symmetrical phases?<br>-Phase Duration<br>(include units)(state<br>range, if<br>applicable)(both<br>phases, if<br>asymmetrical) | Yes.<br>Symmetrical, 300 µs | Yes<br>Symmetrical, 300 - 400 µs | Yes<br>Symmetrical, 175 µs |
| Net Charge [µC/Pulse] | 0 [µC] @ 500Ω<br>Excitation pulse fully<br>compensated | 0 [µC] @ 500Ω<br>Excitation pulse fully<br>compensated | 0.5 [µC] @ 500Ω<br>Excitation pulse fully<br>compensated |
| Maximum Phase Charge<br>[µC] | 21 [µC] @ 500Ω | 48 [µC] @ 500Ω | 21 [µC] @ 500Ω |
| Maximum Current<br>(RMS) Density<br>[mA/cm2] | 0.032 mA/cm2 @ 500Ω | 1.49 mA/cm2 @ 500Ω | 0.788 mA/cm2 @ 500Ω |
| Maximum Power<br>Density [mW/cm2] | 1.25 mW/cm2 @ 500Ω | 27.6 mW/cm2 @ 500Ω | 8.16 mW/cm2 @ 500Ω |

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| Element | New Device:<br>FastFit EMS System | Primary Predicate:<br>Compex Wireless USA | Secondary Predicate:<br>Katalyst Mark 1 Muscle<br>Stimulation System Model 2 |
|------------|-----------------------------------|-------------------------------------------|------------------------------------------------------------------------------|
| Burst Mode | N/A | Not publicly available | N/A |
| ON Time | 4 second intervals | Not publicly available | 4 second intervals |
| OFF Time | 4 second intervals | Not publicly available | 4 second intervals |

## SUMMARY OF SIMILARITIES / DIFFERENCES:

The FastFit EMS system provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities in the same way as both the predicate devices. All three devices are intended to be used in addition to physical exercise to stimulate healthy muscles in order to improve or facilitate muscle performance. The same fundamental technology platform is employed by all three devices. These devices are all comprised of a set of electrodes powered by a portable battery pack that can deliver an electrical stimulation that is adjustable by the user through a wireless remote user interface. The FastFit EMS system and the Katalyst Mark I both have their electrodes integrated into a wearable body suit, whereas the Compex® Wireless USA allows for each electrode to be independently positioned at the users' discretion.

One notable difference between the FastFit EMS system and the predicate devices is that the FastFit EMS delivers EMS with a much lower maximum current density and power density. This can be accomplished because the FastFit EMS system uses a larger electrode surface area and a lower duty cycle. A lower maximum current and power density for the FastFit represents a lower risk to the user in comparison to the predicate devices.

Another notable difference is in the interface application. The FastFit EMS uses a software application that downloads onto a mobile device (such as a smartphone), whereas the Compex® Wireless uses a software application installed on a proprietary remote device and the Katalyst Mark I uses a software application on a commercially available tablet (Microsoft Surface). Although a few other minor differences exist between the subject and predicate devices (see Basis for Substantial Equivalence Table), these differences do not adversely impact the safety and effectiveness of the subject device.

## SUMMARY OF NONCLINICAL TESTING:

Comprehensive design verification and validation testing was performed on the FastFit EMS system. Results from bench and animal testing demonstrated that the function, performance, and safety of the device meet its intended use. Testing performed included a combination of the following:

- System Design Verification Testing ●
- Software Verification and Validation ●

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- Electrical Safety Testing (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-10) ●
- . Electromagnetic Compatibility Testing (IEC 60601-1-2)
- Biocompatibility Testing (ISO 10993-1, ISO 10993-5, and ISO 10993-10) ●
- Usability/Human Factors Testing

Overall, testing confirmed that the FastFit EMS system can be used according to its intended use and in an equivalent manner to the predicate device.

## CONCLUSION:

The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues. Based on the above information. FastFit believes that the substantial equivalence of the FastFit EMS system to the Compex Wireless USA and Katalyst Mark 1 has been demonstrated.