E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. Fit-Pro Ltd. Janos Papp CEO 7 Szabadsag Ter Budapest. 1054 Hungary Re: K202148 Trade/Device Name: E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 23, 2021 Received: July 23, 2021 Dear Janos Papp: 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 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 {1}------------------------------------------------ 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 mediation-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, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K202148 Device Name E-Fit Infinity System (EF-100 +EF-2090) Indications for Use (Describe) The E-Fit Infinity System is designated to prescription use (Rx) only. E-Fit Infinity system (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit Infinity system's electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # K202148 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 The assigned 510(k) number is: K202148 #### 1. Submitter information (21 CFR 807.92(a)(1)): | Submitter: | Fit-Pro Ltd. | |-----------------|-------------------------------------| | Address: | 6th floor, 7 Szabadsag square | | | Hungary, Budapest 1054 | | Phone number: | 0036304772460 | | Contact person: | Janos dr. Papp<br>Managing Director | | Summary date: | 08 May 2020 | #### 2. Device information (21 CFR 807.92(a)(2)): | Name of the device: | E-Fit Infinity System | |----------------------------|---------------------------------------------------------| | Common name of the device: | Stimulator, Muscle, Powered, For Muscle<br>Conditioning | | Trade name of the device: | E-Fit EF-2090 and EF-100 Unit | | Common name of the device: | E-Fit Infinity System | | Classification: | 21 CFR 890.5850. Class II, IPF | #### Identification of Legally Marketed Device(s) (21 CFR 807.92(a)(3)): 3. | Name of the legally marketed device: | E-FIT EF-1280 EMS MACHINE | |--------------------------------------|---------------------------| | Manufacturer: | Fit-Pro Ltd. | | 510(k) number: | K133225 | {4}------------------------------------------------ #### 4. Description of the device (21 CFR 807.92(a)(4)): E-Fit Infinity System (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit Infinity 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 generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training. # 4.1. Explanation of the E-Fit Infinity System functions The E-Fit Infinity System with electrical muscle stimulation is the part of the E-FIT EMS model's family, which is also based on EMS technology. The device is specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes # 4.2. Scientific concepts that form the basis for the E-Fit Infinity System The E-Fit Infinity System's electrical impulses allow to trigger action potentials on motor neurons (excitations). These excitations are transmitted to the muscle fibres via the motor end plate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, length of the session), different types of muscle work can be imposed on the stimulated area. The various types of muscle work that the E- Fit Infinity System can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity System may therefore be considered a technique of muscle training. {5}------------------------------------------------ ### FIRMWARE SAFETY FEATURES: #### 4.2.1. Self-test Safety feature to self-check all 12 channel's safe and proper functioning after turning the device on. If a channel's output signal falls out of the safe range, the device further use will be disabled, and the display will show 'SELFTEST FAILED'. The cause might be external factor (humidity, temperature) or any hardware malfunction. #### 4.2.2. Health protection Health protection is a safety hardware-based feature to turn off the modulation and stop output signals if power amplifier panel transistors have shortcuts or multiple parallel outputs become active due to hardware or software error. Health protection always protects user from unpleasant electric sensation, even if main processor crashes. #### 4.2.3. Impulse-shift technology (IST) IST, developed by E-Fit engineers, is a unique method that shifts impulses in time between different channels. This means that only one muscle group is stimulated at any given moment. Therefore, the full output performance of the device will be equal to the power of only one channel, reducing overall impulse-load on client. The biggest advantage of this solution is that cross-impulses between channel-pairs can be eliminated. #### 4.2.4. Electrical Conductivity test (no load trip) No Load Trip test is an electrical conductivity test running continuously on every channel. It checks the electrical resistance of cables and electrodes in the specified range (*400Ω -~20kΩ) on all channels. If a cable is broken or an electrode is not in proper contact, the given channel will turn off and will be marked red on the RUN screen. In this case conductivity (dampening) of electrodes and cable integrity must be checked. This test impulse package runs through fast at the end of each stimulation (signal parameters: bipolar, square impulses, P. Width: 100 µs, Freq.: 1 Hz, current power: 2 mA, length (12 bipolar channels): 0.02 sec). # 4.3. Significant physical and performance characteristics of the E-Fit Infinity System ### EF-100 wireless unit (ME device) technical parameters: | Unit size (calc.): | 6.1 x 3.9 x 1.1" (155x98x28mm) | |----------------------|----------------------------------------| | Unit weight (calc.): | 0.88 lb (0.4kg) | | Display: | Size: 3.2 inch | | | type: RGB 65K true to life colors, TFT | | | Resolution: 240 by 320 pixel | {6}------------------------------------------------ | Memory: | Built in 4MB flash memory | |-------------------------|-------------------------------------------------------------------------------| | Storage capacity: | 2GB micro SD card | | Battery: | Built in Li-Polymer 2x3.7V/3.2Ah | | Runtime: | Up to 5 training hours | | Ports: | 2* 12 pin SP (jacket and short) | | | 1* 9 – 12V/1A DC | | Supply connection: | 1*12V DC | | Wireless communication: | IEEE 802.15.4. RF module (FCC (USA), IC<br>(Canada), ETSI (Europe) Certified) | | Output: | Maximal power: 1.62W | | | Maximal current density: | | | 0.9mA/cm2 Current intensity | | | (peak): 0-75mA RMS | | | current/channel: 2.975mA | | | Voltage range: 0-48V | | | No. of channels: 12 | | | Output waveform: Modulated<br>bipolar square | | | Impulse parameters: | | | i. Frequency: 4-90Hz | | | ii. Pulse width: 100-500μs | | | iii. Contraction time: 0.1-30s | | | iv. Relax time: 0.3-30s | | | v. Ramp up time: 0-5s | | | vi. Ramp Down time: 0-5s | | | vii. Training time: 1-30min | {7}------------------------------------------------ | User interface: | 5*Pushbutton | |-----------------|------------------------| | | 4* LED status feedback | | | Graphic User Interface | | | (GUI) | # EF-2090 controller technical parameters: | Device size (calc.):<br>Device weight (calc.): | 15 x 11.3 x 2.7" (380x286x69mm)<br>4.9 lb (2.2kg) | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Display: | Size: 10.1 inch<br>Type: Capacitive touchscreen, TFT<br>View angle: 170°<br>Maximal brightness: 350cd/m2<br>Resolution: 1280 by 800 pixel | | Storage capacity: | 32 GB SSD | | Battery: | Built in Li-Ion 7.2V/2.6Ah | | Runtime: | Up to 2 hours | | Supply connection: | 1*12V DC | | Power consumption: | max. 60W | | Wireless communication: | 802.11 b/g/n (Range up to 50m)<br>IEEE 802.15.4. RF module (FCC (USA), IC<br>(Canada), ETSI (Europe) Certified) | | User interface: | 6* heavy duty encoders with push<br>function<br>1*multifunctional "E-button"<br>Graphic touch screen User Interface (GUI) | {8}------------------------------------------------ #### 5. Intended use of the device (21 CFR 807.92(a)(5)): E-Fit Infinity System (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit Infinity 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 generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training. The device has one-channel amplifier that controls the 12 channels in time shifted way according to the previously adjusted parameters. Therefore, unwanted cross-impulses are prevented between the electrodes. This technology ensures that during the operation it is not necessary to switch and/or replace the electrodes on the different body parts. This provides a long life for the electrodes and reduces any possibility of skin irritation. The electrodes are well-placed according to the direct placement standards: into designed cotton, portable uniform with an adjustable rubber band cover. Therefore, misplacement or any harmful risk-taking is physically impossible. (Ex. Neck area, head, genitals etc.) User-friendly GUI helps the Operator to manage the System. Default programs (built-in by the manufacturer) are included in the Remote Controller. The parameters and the channel intensities can be adjusted separately according to the regulations and the given measuring protocol. The main cable from the low-powered, and low-voltage output unit needs to be attached to the client's Technical Wear with the corresponding connectors, reversed or mismatched connections are not possible. The Technical Wear ensures that the electrodes will stay in place despite any misconnection of given electrodes due to operator error. The clients must wear underclothes designed by the manufacturer for hygiene and to save the condition of the electrodes. Placement of the electrodes is not allowed directly on the skin! The Page 6 of 12 {9}------------------------------------------------ electrodes are already fitted in the Technical Wear, the operator needs only to slightly reposition, according to the client's muscles. The electrodes can be conductive via tap water which is applied on the surface of the cotton layer during the treatment. The electrodes are washable and disinfectable. The E-Fit Infinity System has the same intended use and similar technological characteristics and principles as the predicate device. Moreover, verification and validation tests contained in this submission demonstrate that the small differences in E-Fit Infinity System still maintains the same safety and effectiveness as that of the cleared device. In other words, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the device. The operation that includes the delivery of small amount of electrical stimulation to skeletal muscles for conditioning of the muscles. ### 6. Summary of the technological characteristics of the new device in comparison to those of the predicate device (21 CFR 807.92(a)(6)): | Parameter/application | E-Fit Infinity System | E-Fit EF-1280 (K133225) | Result | |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Powered Muscle<br>Stimulator | YES | YES | same | | Regulated | YES | YES | same | | Output<br>specification<br>according to the<br>Basic Unit<br>characteristics<br>document | Max Output Voltage = 37,2V<br>@ 500 Ω | Max Output Voltage =<br>36 V @ 500 Ω | similar | | | Max Output Current = 75mA<br>@ 500 Ω | Max Output Current =<br>72 mA @ 500 Ω | similar | | | Max Phase Charge = 26μC @<br>500 Ω | Max Phase Charge = 36μC @<br>500 Ω | similar | | | Maximum Current Density =<br>0,9365 mA/cm2 @500 Ω | Maximum Current Density =<br>0,85 mA/cm2 @500 Ω | similar | | | Maximum Power Density =<br>0,0342W/ cm2 @500 Ω | Maximum Power Density =<br>0.0063W/ cm2 @500 Ω | similar | | Maximum Output<br>Current | 75mA (peak)/ 2.975mA<br>(r.m.s.) | 72 mA(peak) | similar | | Maximum Output<br>Voltage | 0-48V | 0-36V | similar | | Number of channels | 1 output channel can shift<br>in time between the 12<br>outputs and electrical<br>current can be regulated<br>individually on every | 1 output channel can shift<br>in time between the 12<br>outputs and electrical<br>current can be regulated<br>individually on every output | same<br>multichannel<br>method | | | output | | | | Waveforms | Symmetric biphasic | Symmetric biphasic | same | | Output frequency | 4-90 Hz | 5-120 Hz | similar | | Positive pulse width | 100-500µsec | 100-500µsec | same | | Negative pulse width | 100-500µsec | 100-500µsec | same | | Number of programs | 6+93 | 5+5 | new device has<br>larger memory<br>to store<br>customer<br>programs, the<br>default<br>programs are<br>the same as<br>predicate<br>device | | Program duration | Maximum 30 min. | Maximum 30 min. | same | | Power source -<br>Battery | 2x 3,7V (3,2Ah) Li-<br>PO, tested by IEC62133<br>and UN38.3 | 12V (3,4Ah) lead Acid | similar low<br>voltage<br>batteries | | Size of the electrodes | Electrodes with pre-<br>defined (supplied with the<br>device) site and correct<br>position. | Electrodes with pre-<br>defined (supplied with the<br>device) site and correct<br>position. | same | | User interface | The wireless controller has<br>rotary encoder which allows<br>for a quick set-up, and<br>because of the push button<br>capability, the program can<br>be stopped immediately for<br>every channel. There are<br>large START/STOP and<br>POWER off buttons to begin<br>the program and for<br>complete power shutdown.<br>Because of the<br>pictographs on the<br>displays and fixed<br>electrodes in the clothing,<br>it is very easy to set the<br>appropriate muscle | The wired controller has<br>rotary encoder which<br>allows for a quick set-up,<br>and because of the push<br>button capability, the<br>program can be stopped<br>immediately for every<br>channel.<br>There are large START/STOP<br>and POWER off buttons to<br>begin the program and for<br>complete power shutdown.<br>Because of the pictographs<br>and fixed electrodes in the<br>clothing, it is very easy to<br>set the appropriate muscle<br>groups. | Our older<br>device which<br>we want to use<br>as a predicate<br>device has<br>wired<br>controller,<br>while the new<br>device has a<br>wireless<br>controller. All<br>the functions<br>and control<br>encoders are<br>the same. The<br>unit has the<br>same physical<br>buttons as the<br>older predicate<br>device. | | | groups. | | user has an<br>additional<br>emergency<br>power-off<br>button next to<br>his hand, plus<br>there are no<br>long remote<br>controller<br>cables around<br>during training,<br>so the new<br>construction is<br>safer. | | Safety circuits | Short-circuit monitoring,<br>watchdog monitoring, no<br>load trip, onload trip, battery<br>monitoring, battery voltage<br>monitoring, output current<br>monitoring (emergency STOP<br>option), option for self- test,<br>hardware error monitoring. | Short-circuit monitoring,<br>watchdog monitoring, no<br>load trip, onload trip,<br>battery monitoring, battery<br>voltage monitoring, output<br>current monitoring<br>(emergency STOP option),<br>option for self-test,<br>hardware error monitoring. | same | | Portability/Mobile<br>Use | Portable with difficulty, no<br>mobile device, its<br>intended use requires the<br>qualified and trained<br>operator. | Portable with difficulty, no<br>mobile device, its intended<br>use requires the qualified<br>and trained operator. | same | | Material of the<br>enclosure | Polyamide and carbon<br>fiber | Stainless steel | Different<br>housing<br>material.<br>However, both<br>devices have<br>been<br>successfully<br>tested<br>according to<br>the relevant<br>recognized<br>safety<br>standards<br>(IEC60601) | | Intended use | EF Infinity is intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance. | EF 1280 is intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance. | same | | Operator | By manufacturer<br>recommendations, the only<br>person who can operate the<br>device must obtain<br>certifications provided by<br>the seller. This person must<br>complete the certification<br>prior to use on a patient. | By manufacturer<br>recommendations, the only<br>person who can operate the<br>device must obtain<br>certifications provided by<br>the seller. This person must<br>complete the certification<br>prior to use on a patient. | same | | Menu/Settings | Simple one-level menu<br>system | Simple one-level menu<br>system | same | | Plug | Cables connect to the<br>electrodes with snap<br>fastener and connect to<br>the machine with plastic<br>connector. | Cables connect to the<br>electrodes with snap<br>fastener and connect to the<br>machine with plastic<br>connector. | same | | Lead wires - cables | SIFF 0.5-1.5mm2 (1x375<br>unique filaments) ultra-<br>flexible - Compliant with<br>protected lead wire and<br>patient cable safety<br>requirements. | SIFF 0.5-1.5mm2 (1x375<br>unique filaments) ultra-<br>flexible - Compliant with<br>protected lead wire and<br>patient cable safety<br>requirements. | same | | Conductivity of the<br>electrodes | The subject needs to put on<br>a 100% hygroscopic cotton<br>underwear (surgery textile,<br>biocompatibility certified)<br>and these underwear needs<br>to be soaked/irrigated with<br>normal tap water. So, the<br>electro conductive media is<br>simply tap watered cotton<br>which is in contact with the<br>electrodes. The surface of<br>the electrode will not get<br>dry. In this case the pulse<br>transmission efficiency will<br>not decrease. The small | The subject needs to put<br>on a 100% hygroscopic<br>cotton underwear (surgery<br>textile, biocompatibility<br>certified) and these<br>underwear needs to be<br>soaked/irrigated with<br>normal tap water. So, the<br>electro conductive media<br>is simply tap watered<br>cotton which is in contact<br>with the electrodes. The<br>surface of the electrode<br>will not get dry. In this case<br>the pulse transmission | same | | | conductive pads are<br>washable and disinfectable. | efficiency will not<br>decrease. The small<br>conductive pads are<br>washable and<br>disinfectable. | | | Soldering of the<br>printed Circuit Boards | According to the ROHS<br>directive there is no lead<br>solder material used. | According to the ROHS<br>directive there is no lead<br>solder material used. | same | | Placement of the<br>electrodes | Appropriately pre-placed in<br>specific areas according to<br>muscle anatomy. | Appropriately pre-placed<br>in specific areas according<br>to muscle anatomy. | same | | Reusable pads | YES | YES | same | | Display | EF100: 3.5" TFT display<br>EF-2090: 10" Touch screen<br>TFT display | LCD 2*40 characters LCD<br>display with LED backlight | different, new<br>devices have a<br>larger and<br>higher<br>resolution<br>display. | | Statistical functions | statistical functions –<br>counting the hours of<br>operation | statistical functions -<br>counting the hours of<br>operation | same | # 6.1. Technical characteristics {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ # 6.2. Summary of Testing and Comparison to the Predicate Device E-Fit Infinity System and the predicate device have the same indications for use and very similar technological characteristics and features. E-Fit Infinity System has a wireless remote controller instead of long wired connection and this solution is better as a safe peer communication and avoids ESD phenomena (static discharge). Accidents due to the long cable during the therapy (movements, exercises) are eliminated. The ME device (EF-100) has all the necessary features to be a stand-alone device in itself: user interface, emergency stop button, indicator LEDs, display to show the treatment parameters. There are a few design differences between the E-Fit Infinity System and the predicate device. However, these differences do not raise new questions for safety or efficacy. Specifically, the only technological difference between the E-Fit Infinity System and its predicate is the shape and material of the stimulator, and the user interface (larger display). These differences do not present any new issues in safety or effectiveness, as the E-Fit Infinity System is substantially similar to the predicate device. Concerns of safe and proper use of electrodes and electrode pad placement have been fully addressed by making the user {14}------------------------------------------------ conscious of the proper placement of the electrodes and proper operation of the device through details in the User's Instruction Manual. The electrodes and structure of the technical wear is the same as the predicate device's safety and effectiveness has improved via the educated trainer/operator's proper treatment skill. We guarantee that there are no new safety or effectiveness issues concerning this device to be introduced. The new device design method and design changes are recorded and performed according to the quality management system (ISO 13485, FDA 21 CFR 820.30). The safety of the device, to be used for the proposed indications without medical prescriptions or supervision, is established by the fact that no adverse events have ever been reported since 2010 after over 6 million trainings on devices all over the world manufactured by Fit-Pro Ltd, using a platform equivalent to the predicate device, without a prescription. Over 60,000 trainings - from the 6 million - took place by using E-Fit Infinity System worldwide. The effectiveness of the device for the proposed indications is supported by a number of articles in peer-reviewed publications, which demonstrate that electrical stimulation does improve muscle performance and condition. The new device is designed and manufactured in accordance with the latest international standards. ### 6.3. Conclusion of Substantial Equivalence The E-Fit Infinity System was designed, manufactured and tested in the same factory as the predicate device under the same conditions according to the relevant standards and quality management system. All design, testing and manufacturing processes are recorded and validated according to the required FDA and ISO regulations. The device has the same intent of use and same indications and contraindications. All the accessories {patient cables and electrodes) are similar. There are no differences which can raise any new issues regarding safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device