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.

Device Description

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'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.

AI/ML Overview

The provided text is a 510(k) summary for the E-Fit Infinity System, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for device performance. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies) is not directly available in the provided document.

However, I can extract the following relevant information and address the questions to the best of what's provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial's endpoints and thresholds for success. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (E-FIT EF-1280 EMS MACHINE, K133225) by comparing its technological characteristics and by referencing the predicate's safety record and published literature.

The table below summarizes the technical characteristics comparison, which serves as the basis for proving "performance" through equivalence. The "Result" column effectively indicates whether the new device meets the "acceptance criterion" of being similar to the predicate.

Parameter/application	E-Fit Infinity System Performance (Reported)	Predicate Device Performance (E-Fit EF-1280, K133225)	Acceptance Criterion (Similarity to Predicate)
Powered Muscle Stimulator	YES	YES	same
Regulated	YES	YES	same
Max Output Voltage @ 500 Ω	37.2V	36 V	similar
Max Output Current @ 500 Ω	75mA	72 mA	similar
Max Phase Charge @ 500 Ω	26μC	36μC	similar
Maximum Current Density @ 500 Ω	0.9365 mA/cm²	0.85 mA/cm²	similar
Maximum Power Density @ 500 Ω	0.0342W/cm²	0.0063W/cm²	similar
Maximum Output Current (peak/r.m.s.)	75mA (peak)/ 2.975mA (r.m.s.)	72 mA (peak)	similar
Maximum Output Voltage	0-48V	0-36V	similar
Number of channels	1 output channel can shift in time between the 12 outputs and electrical current can be regulated individually on every output	1 output channel can shift in time between the 12 outputs and electrical current can be regulated individually on every output	same multichannel method
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 (larger memory for customer programs; default programs same as predicate)	5+5	New device has larger memory
Program duration	Maximum 30 min.	Maximum 30 min.	same
Power source - Battery	2x 3.7V (3.2Ah) Li-PO, tested by IEC62133 and UN38.3	12V (3.4Ah) lead Acid	similar low voltage batteries
Size of the electrodes	Pre-defined (supplied with the device) site and correct position.	Pre-defined (supplied with the device) site and correct position.	same
User interface	Wireless controller with rotary encoder, push button capability, large START/STOP and POWER off buttons, pictographs, fixed electrodes in clothing. User has additional emergency power-off button. No long remote controller cables. New construction is safer.	Wired controller with rotary encoder, push button capability, large START/STOP and POWER off buttons, pictographs, fixed electrodes in clothing.	Similar functions, new device is safer
Safety circuits	Short-circuit monitoring, watchdog monitoring, no load trip, onload trip, battery monitoring, battery voltage monitoring, output current monitoring (emergency STOP option), option for self-test, hardware error monitoring.	Short-circuit monitoring, watchdog monitoring, no load trip, onload trip, battery monitoring, battery voltage monitoring, output current monitoring (emergency STOP option), option for self-test, hardware error monitoring.	same
Portability/Mobile Use	Portable with difficulty, not a mobile device, requires qualified and trained operator.	Portable with difficulty, not a mobile device, requires qualified and trained operator.	same
Material of the enclosure	Polyamide and carbon fiber	Stainless steel	Different housing material, both tested to IEC60601
Intended use	Stimulate healthy muscles to improve or facilitate muscle performance.	Stimulate healthy muscles to improve or facilitate muscle performance.	same
Operator	Certified by seller.	Certified by seller.	same
Menu/Settings	Simple one-level menu system	Simple one-level menu system	same
Plug	Cables connect to electrodes with snap fastener, to machine with plastic connector.	Cables connect to electrodes with snap fastener, to machine with plastic connector.	same
Lead wires - cables	SIFF 0.5-1.5mm² (1x375 unique filaments) ultra-flexible - Compliant with protected lead wire and patient cable safety requirements.	SIFF 0.5-1.5mm² (1x375 unique filaments) ultra-flexible - Compliant with protected lead wire and patient cable safety requirements.	same
Conductivity of the electrodes	Tap watered cotton underwear, washable and disinfectable pads.	Tap watered cotton underwear, washable and disinfectable pads.	same
Soldering of the Printed Circuit Boards	According to ROHS directive (no lead solder).	According to ROHS directive (no lead solder).	same
Placement of the electrodes	Appropriately pre-placed in specific areas according to muscle anatomy.	Appropriately pre-placed in specific areas according to muscle anatomy.	same
Reusable pads	YES	YES	same
Display	EF100: 3.5" TFT display; EF-2090: 10" Touch screen TFT display	LCD 2*40 characters LCD display with LED backlight	Different (larger, higher resolution)
Statistical functions	Counting the hours of operation	Counting the hours of operation	same

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a traditional "test set" from a clinical study for the E-Fit Infinity System. Instead, it relies on the safety record of the predicate device and the new device.

Predicate Device Safety Data: "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."
- Sample Size: "over 6 million trainings"
- Data Provenance: Worldwide, retrospective (data collected since 2010).
New Device (E-Fit Infinity System) Safety Data: "Over 60,000 trainings - from the 6 million - took place by using E-Fit Infinity System worldwide."
- Sample Size: "Over 60,000 trainings"
- Data Provenance: Worldwide, retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the submission relies on equivalence and existing safety records, not a specific clinical study involving experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the submission does not detail a clinical study with an adjudication process for a test set.

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

This is not applicable. The device is an electronic muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or referenced.

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

This is not applicable. The device is a physical muscle stimulator, not an algorithm. Its performance is evaluated through its technical specifications and safety record.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For safety, the ground truth is indirectly based on the absence of adverse events from a large number of past uses (outcomes data in a broad sense).
For effectiveness, the ground truth is established by referencing published articles in peer-reviewed publications that "demonstrate that electrical stimulation does improve muscle performance and condition." This is a form of scientific consensus/literature review acting as the ground truth.

8. The sample size for the training set

This is not applicable. The E-Fit Infinity System is a hardware device, not a machine learning model that requires a training set in that context. The "training" implied here refers to the extensive safety record of the predicate device and the initial use of the new device itself.

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

As per point 8, this is not applicable in the context of a machine learning training set. The safety and effectiveness claims are based on:

The long-term safety record of the predicate device (over 6 million trainings without adverse events).
Published peer-reviewed literature supporting the efficacy of electrical muscle stimulation for muscle performance and conditioning.
The E-Fit Infinity System itself having accumulated over 60,000 trainings without reported adverse events.

Summary

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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

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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

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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.

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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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. PappManaging 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 MuscleConditioning
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

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4. Description of the device (21 CFR 807.92(a)(4)):

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.

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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

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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(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: Modulatedbipolar 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

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User interface:	5*Pushbutton
	4* LED status feedback
	Graphic User Interface
	(GUI)

EF-2090 controller technical parameters:

Device size (calc.):Device weight (calc.):	15 x 11.3 x 2.7" (380x286x69mm)4.9 lb (2.2kg)
Display:	Size: 10.1 inchType: Capacitive touchscreen, TFTView angle: 170°Maximal brightness: 350cd/m2Resolution: 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)IEEE 802.15.4. RF module (FCC (USA), IC(Canada), ETSI (Europe) Certified)
User interface:	6* heavy duty encoders with pushfunction1*multifunctional "E-button"Graphic touch screen User Interface (GUI)

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5. Intended use of the device (21 CFR 807.92(a)(5)):

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 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

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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 MuscleStimulator	YES	YES	same
Regulated	YES	YES	same
Outputspecificationaccording to theBasic Unitcharacteristicsdocument	Max Output Voltage = 37,2V@ 500 Ω	Max Output Voltage =36 V @ 500 Ω	similar
	Max Output Current = 75mA@ 500 Ω	Max Output Current =72 mA @ 500 Ω	similar
	Max Phase Charge = 26μC @500 Ω	Max Phase Charge = 36μC @500 Ω	similar
	Maximum Current Density =0,9365 mA/cm2 @500 Ω	Maximum Current Density =0,85 mA/cm2 @500 Ω	similar
	Maximum Power Density =0,0342W/ cm2 @500 Ω	Maximum Power Density =0.0063W/ cm2 @500 Ω	similar
Maximum OutputCurrent	75mA (peak)/ 2.975mA(r.m.s.)	72 mA(peak)	similar
Maximum OutputVoltage	0-48V	0-36V	similar
Number of channels	1 output channel can shiftin time between the 12outputs and electricalcurrent can be regulatedindividually on every	1 output channel can shiftin time between the 12outputs and electricalcurrent can be regulatedindividually on every output	samemultichannelmethod
	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 haslarger memoryto storecustomerprograms, thedefaultprograms arethe same aspredicatedevice
Program duration	Maximum 30 min.	Maximum 30 min.	same
Power source -Battery	2x 3,7V (3,2Ah) Li-PO, tested by IEC62133and UN38.3	12V (3,4Ah) lead Acid	similar lowvoltagebatteries
Size of the electrodes	Electrodes with pre-defined (supplied with thedevice) site and correctposition.	Electrodes with pre-defined (supplied with thedevice) site and correctposition.	same
User interface	The wireless controller hasrotary encoder which allowsfor a quick set-up, andbecause of the push buttoncapability, the program canbe stopped immediately forevery channel. There arelarge START/STOP andPOWER off buttons to beginthe program and forcomplete power shutdown.Because of thepictographs on thedisplays and fixedelectrodes in the clothing,it is very easy to set theappropriate muscle	The wired controller hasrotary encoder whichallows for a quick set-up,and because of the pushbutton capability, theprogram can be stoppedimmediately for everychannel.There are large START/STOPand POWER off buttons tobegin the program and forcomplete power shutdown.Because of the pictographsand fixed electrodes in theclothing, it is very easy toset the appropriate musclegroups.	Our olderdevice whichwe want to useas a predicatedevice haswiredcontroller,while the newdevice has awirelesscontroller. Allthe functionsand controlencoders arethe same. Theunit has thesame physicalbuttons as theolder predicatedevice.
	groups.		user has anadditionalemergencypower-offbutton next tohis hand, plusthere are nolong remotecontrollercables aroundduring training,so the newconstruction issafer.
Safety circuits	Short-circuit monitoring,watchdog monitoring, noload trip, onload trip, batterymonitoring, battery voltagemonitoring, output currentmonitoring (emergency STOPoption), option for self- test,hardware error monitoring.	Short-circuit monitoring,watchdog monitoring, noload trip, onload trip,battery monitoring, batteryvoltage monitoring, outputcurrent monitoring(emergency STOP option),option for self-test,hardware error monitoring.	same
Portability/MobileUse	Portable with difficulty, nomobile device, itsintended use requires thequalified and trainedoperator.	Portable with difficulty, nomobile device, its intendeduse requires the qualifiedand trained operator.	same
Material of theenclosure	Polyamide and carbonfiber	Stainless steel	Differenthousingmaterial.However, bothdevices havebeensuccessfullytestedaccording tothe relevantrecognizedsafetystandards(IEC60601)
Intended use	EF Infinity is intended tostimulate healthy musclesin order to improve orfacilitate muscleperformance.	EF 1280 is intended tostimulate healthy musclesin order to improve orfacilitate muscleperformance.	same
Operator	By manufacturerrecommendations, the onlyperson who can operate thedevice must obtaincertifications provided bythe seller. This person mustcomplete the certificationprior to use on a patient.	By manufacturerrecommendations, the onlyperson who can operate thedevice must obtaincertifications provided bythe seller. This person mustcomplete the certificationprior to use on a patient.	same
Menu/Settings	Simple one-level menusystem	Simple one-level menusystem	same
Plug	Cables connect to theelectrodes with snapfastener and connect tothe machine with plasticconnector.	Cables connect to theelectrodes with snapfastener and connect to themachine with plasticconnector.	same
Lead wires - cables	SIFF 0.5-1.5mm2 (1x375unique filaments) ultra-flexible - Compliant withprotected lead wire andpatient cable safetyrequirements.	SIFF 0.5-1.5mm2 (1x375unique filaments) ultra-flexible - Compliant withprotected lead wire andpatient cable safetyrequirements.	same
Conductivity of theelectrodes	The subject needs to put ona 100% hygroscopic cottonunderwear (surgery textile,biocompatibility certified)and these underwear needsto be soaked/irrigated withnormal tap water. So, theelectro conductive media issimply tap watered cottonwhich is in contact with theelectrodes. The surface ofthe electrode will not getdry. In this case the pulsetransmission efficiency willnot decrease. The small	The subject needs to puton a 100% hygroscopiccotton underwear (surgerytextile, biocompatibilitycertified) and theseunderwear needs to besoaked/irrigated withnormal tap water. So, theelectro conductive mediais simply tap wateredcotton which is in contactwith the electrodes. Thesurface of the electrodewill not get dry. In this casethe pulse transmission	same
	conductive pads arewashable and disinfectable.	efficiency will notdecrease. The smallconductive pads arewashable anddisinfectable.
Soldering of theprinted Circuit Boards	According to the ROHSdirective there is no leadsolder material used.	According to the ROHSdirective there is no leadsolder material used.	same
Placement of theelectrodes	Appropriately pre-placed inspecific areas according tomuscle anatomy.	Appropriately pre-placedin specific areas accordingto muscle anatomy.	same
Reusable pads	YES	YES	same
Display	EF100: 3.5" TFT displayEF-2090: 10" Touch screenTFT display	LCD 2*40 characters LCDdisplay with LED backlight	different, newdevices have alarger andhigherresolutiondisplay.
Statistical functions	statistical functions –counting the hours ofoperation	statistical functions -counting the hours ofoperation	same

6.1. Technical characteristics

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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

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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

Regulation Number and Section

N/A