FLIX-EMS by Casgarum Investment, S.L.

FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy.

FLIX-EMS electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to 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

Device Description

The proposed device is an electro-medical device designed and manufactured for sports and fitness activity with low-intensity electro-stimulation technology. It is intended for stimulating healthy muscles in order to improve or facilitate muscle performance in training procedures with numerous special features.

When used as indicated, FLIX-EMS device is intended for muscle electro-stimulation. Low-intensity electro-stimulation simulates how our central nervous system activates muscle movement. Muscles move thanks to nerve impulses from the brain. These electrical stimuli are passed along nerves to the muscles, where they generate muscle contractions. Low-intensity electro-stimulation uses the same system to encourage muscle training.

The various muscle groups are stimulated using electrodes strategically positioned around the body to generate muscle contractions. The training dynamic combines voluntary movements by the user with muscle contractions generated by the low-intensity electro-stimulation, meaning that the muscle receives more effective stimulation and, in short, a more complete workout.

The electrodes cover most muscle groups and these are activated simultaneously so that the user can train various muscle groups at the same time. The user can train biceps and triceps at the same time, for example, which cannot be done with conventional weight training.

The device consists of an app (dashboard) that enables operating variables to be selected and monitored, an electronic device that controls the selected power supply and a Bluetooth data transmission system.

The suit contains a set of cables that carry the current via an emission system (electrodes) and is connected to the main unit via a master cable.

The FLIX-EMS app enables very simple and convenient operation of all the system software (program). The app is used by physically touching the screen on the terminal in which the app is installed, whether a smartphone, tablet or PC:

The software is a computer program that uses images and graphics to represent the available information and options. Its main purpose is to provide a simple visual interface for enabling communication with the device's operating system.

AI/ML Overview

This looks like a 510(k) summary for a medical device called FLIX-EMS. However, the document does not contain any acceptance criteria or a study proving that the device meets those criteria, as it explicitly states "No clinical studies are submitted."

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical testing against recognized standards.

Therefore, I cannot fulfill your request for acceptance criteria and a study that proves the device meets them based on the provided input. The document explicitly states:

"SUMMARY DISCUSSION OF CLINICAL DATA: Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted."

The "Conclusions" section further reinforces that the substantial equivalence is based on the intended use, indications for use, principle of operation, and compliance with standards through non-clinical testing, not clinical performance studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

May 14, 2019

Casgarum Investment, S.L. Rafael Castillo General Manager Calle Real, 17 Bº E 45200, Illescas Toledo. Spain

Re: K181419

Trade/Device Name: FLIX-EMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 12, 2018 Received: October 1, 2018

Dear Rafael Castillo:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director, Acute Injury Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181419

Device Name FLIX-EMS

Indications for Use (Describe)

FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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"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."

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510(k) Premarket Notification

SECTION 05 - 510(k) Summary

DATE OF SUBMISSION:SUBMITTER NAME:SUBMITTER ADDRESS:	2018-04-19CASGARUM INVESTMENT, S.L.Calle Real, 17 B E45200, IllescasToledo, Spain
CONTACT:TELEPHONE:	Rafael Castillo+34 925 51 26 67
e-mail:	rcasgarum@gmail.com
DEVICE TRADE NAME:COMMON NAME:CLASSIFICATION NAME:	FLIX-EMSSTIMULATOR, MUSCLE, POWEREDStimulator, muscle, powered, for muscle conditioning(21 CFR 890.5850)
PREDICATE DEVICE(S):	E-Fit EF-1280 (K133225)Compex Wireless USA (K170903)

DEVICE DESCRIPTION:

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510(k) Premarket Notification

SECTION 05 - 510(k) Summary

The suit contains a set of cables that carry the current via an emission system (electrodes) and is connected to the main unit via a master cable.

SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, the FLIX-EMS device is compared with the following previously cleared devices:

E-Fit EF-1280 (K133225) -
Compex Wireless USA (K170903)

Comparison of the proposed devices with the predicate devices is summarized in the following table:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICEFLIX-EMS	PREDICATE DEVICEE-Fit EF-1280	PREDICATE DEVICECompex Wireless USA	Comparison
	GENERAL COMPARISON
Classification name	Powered musclestimulator	Powered musclestimulator	Powered musclestimulator	Same
Product code	NGX	NGX	NGX	Same
Regulation number	21 CFR 890.5850	21 CFR 890.5850	21 CFR 890.5850	Same
Panel	Physical Medicine	Physical Medicine	Physical Medicine	Same
Class	Class II	Class II	Class II	Same
510(K) Number	--	K133225	K170903	N/A
	INTENDED USE
Intended use	FLIX-EMS device isintended to stimulatehealthy muscles in orderto improve or facilitatemuscle performance. Itis to be used by adultsonly.FLIX-EMS is not	E-fit EF-1280 is amachine with electronicmuscle stimulationbased on EMStechnology. Regardingits use, the device isspecifically designed asan addition to othersports and for training	The Compex WirelessUSA is an Over-The-Counter device intendedto stimulate healthymuscles in order toimprove or facilitatemuscle performance. It isto be used by adultsonly.	SameFLIX-EMS does notinclude TENS
Characteristic / Feature	COMPARISON OF TECHNOLOGICAL CHARACTERISTICS			Comparison
	PROPOSED DEVICEFLIX-EMS	PREDICATE DEVICEE-Fit EF-1280	PREDICATE DEVICECompex Wireless USA
	intended for adjunctivetherapy in the treatmentof medical diseases andconditions of any kind.None of the FLIX-EMSstimulation programsare designed for injuredor disease afflictedmuscles. Its use onsuch muscles iscontraindicated. Thework imposed on themuscles by the FLIX-EMS programs isdefinitely not suitable forrehabilitation andphysiotherapy.FLIX-EMS electricalimpulses allow thetriggering of actionpotentials onmotoneurones ofmotor nerves(excitations).These excitations ofmotoneurones aretransmitted to themuscle fibers via themotor endplate wherethey generatemechanical muscle fiberresponses thatcorrespond to musclework. Depending on theparameters of theelectrical impulses(pulse frequency,duration of contraction,duration of rest, totalsession duration),different types ofmuscle work can beimposed on thestimulated muscles	muscles. It must beused for only healthymuscles and clients,not for rehabilitationpurposes.The E-Fit EF-1280intended to stimulatehealthy muscles inorder to improve orfacilitate muscleperformance.The E-Fit EF-1280is not intendedto be used inconjunction withtherapy or treatmentof medical diseasesor medical conditionsof any kind.None of the E-Fit EF-1280 training programsis designed forinjured or ailingmuscles and its useon such muscles iscontraindicated.The E-Fit EF-1280electrical impulsesallowthe triggering ofaction potentials onmotoneurones ofmotor nerves(excitations).These excitations ofmotoneurones aretransmitted to themuscle fibers via themotor endplatewhere they generatemechanical musclefiber responses thatcorrespond to musclework. Depending onthe parameters ofthe electricalimpulses (pulsefrequency, durationof contraction.	The Compex Wireless USAis not intended foradjunctive therapy in thetreatment of medicaldiseases and conditions ofany kind. None of theCompex Wireless USAstimulation programs aredesigned for injured ordisease afflicted muscles. Itsuse on such muscles iscontraindicated. The workimposed on the muscles bythe Compex Wireless USAprograms is definitely notsuitable for rehabilitationand physiotherapy.The Compex WirelessUSA electrical impulsesallow the triggering ofaction potentials onmotoneurones of motornerves (excitations).These excitations ofmotoneurones aretransmitted to the musclefibers via the motor endplatewhere they generatemechanical muscle fiberresponses that correspondto muscle work. Dependingon the parameters of theelectrical impulses (pulsefrequency, duration ofcontraction, duration of rest,total session duration),different types of musclework can be imposed on thestimulated muscles. TheCompex Wireless USA maytherefore be considered atechnique of muscle training.The Compex WirelessUSA TENS is used for:• temporary relief of pain
		frequency, durationof contraction,duration of rest, total
Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	Comparison
	FLIX-EMS	E-Fit EF-1280	Compex Wireless USA
		Session duration), differenttypes of muscle work canbe imposed on thestimulated muscles are ableto improve or facilitatemuscle performance.The E-Fit EF-1280 maytherefore be considereda technique of muscletraining.	associated with sore andaching muscles due tostrain from exercise ornormal household andwork activities.• the symptomatic reliefand management ofchronic, intractable painand relief of painassociated with arthritis.
Indications for use	To be used by adultsonly. Must be used foronly healthy musclesand clients. It is notintended to be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.It is designed to be usedtogether with the Flix-ems application fortablets.	To be used by adultsonly. Must be used foronly healthy musclesand client. It is notintended to be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.	To be used by adultsonly. Must be used foronly healthy muscles andclient. It is not intendedto be used in conjunctionwith therapy or treatmentof medical diseases ormedical conditions of anykind.	Similar(Difference is thesoftware applicationwhich controls thedevice)
Prescription/OTC	Prescription use	Prescription use	Over-the-counter	Same as E-fit.Different thanCompex
Use environment	Use in athletic trainingfacilities. Not for useoutdoors	Use in athletic trainingfacilities	Use in athletic trainingfacilities. Outdoor usenot restricted	Similar as E-fit andCompex.FLIX-EMS only forindoor use
Anatomical sites	Electrodes can beapplied to multipleanatomical sites.	Electrodes can beapplied to multipleanatomical sites.	Electrodes can beapplied to multipleanatomical sites.	Same
TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
Powered MuscleStimulator	YES	YES	YES	Same
Power Source - battery	8.4V(3400mA). Twocells Lithium-ion	12V - 3,4AH	Remote: LithiumPolymer (LiPo)rechargeable 3.7[V] /$\ge$ 1500[mAhStimulationModules: LithiumPolymer (LiPo)rechargeable 3.7[V] /$\ge$ 450[mAh]	SimilarFLIX-EMS, is fullyportable, thebattery needs to beLi-ion battery,which is similar toCompex battery
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICEFLIX-EMS	PREDICATE DEVICEE-Fit EF-1280	PREDICATE DEVICECompex Wireless USA	Comparison
Battery operated	YES	YES	YES	Same
Regulated current and/orvoltage	YES, current	YES, current	YES, current	Same as EfitSame as CompexWireless USASimilar to Efit
Current / Voltage	70mA/100V	72mA/36V	100mA/135V	Similar to CompexWireless USASimilar to Efit
Plastic HousingMaterials	PLASTIC	STAINLESS STEEL	PLASTIC	Different than EfitSimilar to Compex
Maximum Output Voltage(V)(+/- 10%)	Toning 1:35V @ $500Ω$100V@ $2kΩ$100V@ $10kΩ$Toning 2:35V100V@ $2kΩ$100V@ $10kΩ$Training 1:35V @ $500Ω$100V@ $2kΩ$100V@ $10kΩ$Training 2:35V100V@ $2kΩ$100V@ $10kΩ$Training 3:35V @ $500Ω$100V@ $2kΩ$100V@ $10kΩ$Training 4:35V100V@ $2kΩ$100V@ $10kΩ$Customisable programs:35V @ $500Ω$100V@ $2kΩ$100V@ $10kΩ$	36 V @ $500 Ω$	Endurance:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Resistance:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Strength:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Explosive Strength:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Potentiation:60 V @ $500 Ω$152 V @ $2 kΩ$132 V @ $10 kΩ$Training Recovery:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Competition Recovery:60 V @ $500 Ω$165 V @ $2 kΩ$165 V @ $10 kΩ$Pre Warmup	Similar to Efit(@ $500 Ω$ : Toning 1,Toning 2, Training1, Training 2,Training 3 andTraining 4)Similar to CompexWireless USA(Maximum outputvoltage is higher forCompex Wirelessin all trainingprograms)Flix-EMS haslimited outputvoltage to 100 V
Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	Comparison
	FLIX-EMS	E-Fit EF-1280	Compex Wireless USA
			60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩMuscle Relaxation:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩPain Relief TENS:180 [V] peak on 10[kΩ]170 [V] peak on 2 [kΩ]58 [V] peak on 500 [kΩ]
	Toninig 1:70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩToning 2:	72 mA @ 500 Ω	Endurance:116 mA @ 500 Ω80 mA @ 2 kΩ15 mA @ 10 kΩResistance:116 mA @ 500 Ω	Similar to Efit(@500 Ω: Toning 1,Toning 2, Training1, Training 2,Training 3 andTraining 4)
	70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩ		80 mA @ 2 kΩ17 mA @ 10 kΩStrength:113 mA @ 500 Ω	Similar to CompexWireless USA(Maximum outputcurrent is higher forCompex Wireless
Maximum Output Current(mA)(+/- 10%)	Training 1:70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩ		80 mA @ 2 kΩ15 mA @ 10 kΩExplosive Strength:	in all trainingprograms)
	Training 2:70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩ		81 mA @ 500 Ω81 mA @ 2 kΩ15 mA @ 10 kΩ
	Training 3:70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩ		Potentiation:117 mA @ 500 Ω80 mA @ 2 kΩ16 mA @ 10 kΩ
	Training 4:70 mA @500Ω50 mA @ 2kΩ10 mA @ 10kΩ		Training Recovery:116 mA @ 500 Ω81mA @ 2 kΩ16 mA @ 10 kΩ
	Customisable programs:70 mA @500Ω50 mA @ 2kΩ		Pre Warmup116 mA @ 500 Ω81 mA @ 2 kΩ15 mA @ 10 kΩ
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	Comparison
	FLIX-EMS	E-Fit EF-1280	Compex Wireless USA
	10 mA @ $10 kΩ$		Muscle Relaxation:116 mA @ 500 Ω81 mA @ 2 kΩ16 mA @ 10 kΩPain Relief TENS:18[mA] peak @10[kΩ]86[mA] peak@2[kΩ]116[mA] peak@500[Ω]
Maximum power density	4.08mW/cm²@500Ω(Smallest electrode)	6.3 mW/cm² @500Ω	27.6 mW/cm² @ 500Ω	Similar to EfitDifferent thanCompex WirelessUSA (Compex USAfeatures a muchhigher value)
Maximum currentdensity	1.45 mA/cm² @ 500Ω(Smallest electrode)	0.85 mA/cm² @ 500Ω	4.8 mA/cm² @ 500Ω	Similar to EfitDifferent thanCompex WirelessUSA (Compex USAfeatures a muchhigher value)
Number of Outputchannels-Synchronous orAlternating?-Method of ChannelIsolation	1 CHANNEL1 output channel canshift in time to the 10outputs but electricalcurrent can be regulatedindividually on everyoutputs.	1 CHANNEL1 output channel canshift in time to the 12outputs but electricalcurrent can beregulated individually onevery outputs	4 CHANNELSSynchronous with 2msecdelay between channels	Similar than E-fitDifferent thanCompex WirelessUSA
Waveform (e.g., pulsedmonophasic, biphasic)(program per program)	Symmetric Biphasic (allprograms)	Symmetric Biphasic (allprograms)	-Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength :Symmetrical Biphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Training Recovery(sameas Active Recovery):Symmetrical Biphasic-CompetitionRecovery (same as	Same as Efit (Allprograms'symmetricbiphasic' in bothcases)Similar to CompexWireless USA (allprograms'symmetricbiphasic' expect forthe 'Pain relief -TENS' butno TENSincluded intheFLIX-EMS
Characteristic / Feature	PROPOSED DEVICEFLIX-EMS	PREDICATE DEVICEE-Fit EF-1280	PREDICATE DEVICECompex Wireless USA	Comparison
Pulse width (μs)	50-400(μs)Toning 1:350 (μs)Toning 2:350 (μs)Training 1:350 (μs)Training 2:150 (μs)Training 3:350 (μs)Training 4:400 (μs)Customisable programs:50-400(μs)	100-500(μs)	Symmetrical Biphasic-Pre-Warmup Program:Symmetrical Biphasic-Muscle Relaxation(sameas Massage):Symmetrical Biphasic-Pain relief TENS (sameas FM): Balanced,asymetrical BiphasicEndurance:200-400 (μs)Resistance:200-400 (μs)Strength:200-400 (μs)Explosive strength:200-400 (μs)Potentiation200-400 (μs)Training recovery:200-400 (μs)Competition recovery:200-400 (μs)Pre warmup:200-400 (μs)Muscle relaxation:200-400 (μs)Pain Relief TENS: 70 to300[µs] (measured at50% of positive pulse)	Device)Similar to Efit (all programs within the range of pulse of Efit except for the 'customisable')Similar to Compex Wireless USA (all programs within the range of Compex except for the 'customisable')
Frequency	5-100 HzToning 1:85 HzToning 2:90 Hz	5-120 Hz	0,5 to 122 HzEndurance:10 HzResistance:50 Hz	Similar to Efit (all programs of FLIX-EMS within the frequency range of the Efit)
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	Comparison
	FLIX-EMS	E-Fit EF-1280	Compex Wireless USA
	Training 1:7 Hz		Strength:75 Hz	Similar to CompexWireless USA
	Training 2:100 Hz		Explosive strength:100 Hz	(all programs ofFLIX-EMS withinthe range of theCompex)
	Training 3:50 Hz		Potentiation:From 1 to 75 Hz
	Training 4:50 Hz		Training recovery:10 Hz
	Customisable program:5-100 HZ		Competition recovery:0,5 Hz
			Pre warmup:4 Hz
			Muscle relaxation:1 Hz
			Pain Relief TENS:5 to 122 Hz
				Same as Efit
Reusable pads	YES	YES	NO	Different thanCompex
Number of programs	6 pre-set programs + 3customizable programs	5+5	22 programs	Similar to EfitDifferent thanCompex WirelessUSA
Program duration	25 min	Maximum 30min	Maximum 60 minutes	Similar to EfitDifferent thanCompex
Electrode dimensions(cm)	12x8x0.1 cm8x6x0.1 cm	Electrodes with pre-defined (supplied withthe device) size andcorrect position	10x5 cm and 5x5 cmself-adhesive pads (FDAcleared)	Similar to CompexWireless USA
User interface	Application on tablet ormobile with Android andBluetoothcommunication. If thecommunication fails, thedevice has a protectionso as not to damage theuser. Through theprogram the level ofeach channel assignedto each muscle is	The rotary encoder allows for a quick set-up and because of the push button capability, the program can be stopped immediately for every channel. There are large START/STOP and POWER off buttons to begin the program and for complete power	User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation programs.	Similar, the FLIX-EMS is controlledby a tablet byBluetooth butsimilar usabilityinterface.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICE	PREDICATE DEVICE	PREDICATE DEVICE	Comparison
	FLIX-EMS	E-Fit EF-1280	Compex Wireless USA
	regulated with itsspecific name and theparameters of eachprogram are selectedwith their exact nameand a START / STOPbutton that starts orstops the process.	shutdown. Becauseof the pictographs andfixed electrodes in theclothing, it is very easyto set the appropriatemuscle groups.
Portability / Mobile Use	Full portable andprotected with siliconesleeve	Portable with difficulty, itis not an easy movabledevice.	Portable (small size)	Similar to CompexDifferent than E-fit
Operator	Only specialized trainersand certified in thesporting use of EMS	Bymanufacturerecommendations,theonly person who canoperate the device mustobtaincertificationsprovided by the seller.This person mustcomplete thecertification prior to useon a patient.	Adults / trainers usingEMS for training	Similar to EfitSimilar to Compex
Menu / Settings	Only one level of menus,with previous selectionof code coach and clientcode	Simple one-level menusystem.	levels/sub-menus,complexmenusystem	Similar to EfitSimilar to Compex
Plugs	Cables connect to theelectrodes with Ø1'8 mmminiature banana.Cables connect to thestimulator device withplastic 14 pin and 8 pinconnectors.	Cables connect to theelectrodes with snapfastener and connect tothe machine with plastic12pin waterproof ip68connector.	Electrodes sticks to theskin and the modulesslide along the electrodesnap until it 'clicks'. Theyare not connected to themachine.	Different than Efit(cables connectingto the electrodes)Different thanCompex
Conductivity of theelectrodes	The subjects needs towear a cotton bodywearand these bodywearneeds to besoaked/irrigated withnormal tap water. So,the electro conductivemedia is simply tapwatered cotton which isin contact with theelectrodes. The surfaceof the electrode will notget dry. In this case, thepulse transmissionefficiency will notdecrease	The subject needs toput on an 100%hygroscopic cottonunderwear (surgerytextile, biocompatibilitycertified) and theseunderwear needs to besoaked/irrigated withnormal tap water. So,the electro conductivemedia is simply tapwatered cotton which isin contact with theelectrodes. The surfaceof the electrode will notget dry. In this case, thepulse transmissionefficiency will notdecrease.	Conductive gel forelectrotherapy is used inconjuction with thedisposable electrodes forconductivity	Similar to EfitDifferent thanCompex
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic / Feature	PROPOSED DEVICEFLIX-EMS	PREDICATE DEVICEE-Fit EF-1280	PREDICATE DEVICECompex Wireless USA	Comparison
		conductive pads arewashable anddisinfectable.
Placement of theelectrodes	Appropriately pre-placedin specific areasaccording to muscleanatomy.	Appropriately pre-placed in specific areasaccording to muscleanatomy.	Self-adhesive on anyarea of the body.	Similar to EfitDifferent thanCompex
Display	Display is on anandroid tablet (LCDtouchscreen) withBluetoothcommunication.	LCD 2x40 characterLCD display with LEDbacklight.	Small -sized LCD colorscreen	Similar to EfitSimilar to Compex
Statistical functions	It records in the tabletand then on the cloudserver the total hoursgrouped by each clientcode and trainer.	Statistical functions –counting the hours ofoperation	Not available	Similar to E-fit
LAB tests performed	ANSI AAMI 60601-1IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006	IEC 60601-1:2005IEC 60601-1-2:2007IEC 60601-1-11:2010IEC 60601-2-10:2012	IEC 60601-1:2005IEC 60601-1-2:2007IEC 60601-1-6:2013IEC 60601-1-11:2010IEC 60601-2-10:2012IEC 62304:2006	Similar to EfitSimilar to CompexWireless USA

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510(k) Premarket Notification

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510(k) Premarket Notification

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510(k) Premarket Notification

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510(k) Premarket Notification

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510(k) Premarket Notification

SECTION 05 - 510(k) Summary

INTENDED USE:

As established in the Indications for Use Statement:

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510(k) Premarket Notification

SECTION 05 - 510(k) Summary

FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

FLIX-EMS 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.

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.

Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:

Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
Electromagnetic compatibility -
FCC Radio Frequency Testing: the FLIX-EMS device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.

The new device is designed and manufactured in accordance with the following recognized standards:

ANSI AAMI 60601-1:2005/(R)2012 And A1:2012 ●
IEC 60601-1-2:2007

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510(k) Premarket Notification

SECTION 05 - 510(k) Summary

60601-2-10 Edition 2.1 2016-04 ●
IEC 60601-1-6 Edition 3.1 2013-10 ●
ISO 14971 Second Edition 2007-03-01 ●
EN ISO 13485:2003 +/AC2009 ●
IEC 62304:2006

SUMMARY DISCUSSION OF CLINICAL DATA:

Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.

CONCLUSIONS:

We believe the intended use, the indications for use and principle of operation of FLIX-EMS are the same as the intended use, indications for use and performance of the predicate device.

We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).

1. General information of the proposed and predicate devices is the same

Intended use and indications/principle of operations of proposed device and predicate devices are the same.

1. There are minimum differences in the technological characteristic/performance data of the proposed device and those of the predicate devices, all of them comply with IEC 60601 and applicable collateral and particular standards. Thus, the SE is not affected.
  Based on the information provided in this premarket notification, CASGARUM INVESTMENT, S.L., concludes that FLIX-EMS is substantially equivalent to the predicate device with reqard to safety and effectiveness.

Regulation Number and Section

N/A