E-Fit EP-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding is use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy museles and clients, not for rehabilitation purposes.

The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit EF-1280 training programs is designed for injured or alling muscles and its use on such muscles is contraindicated.

The E-Fit EF-1280 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, and fotal session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the E-Fit E-Fit E-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF-1280 may therefore be considered a technique of muscle training.

Device Description

E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

AI/ML Overview

The provided document is a 510(k) summary for the E-Fit EF-1280, a powered muscle stimulator. In these types of FDA submissions, acceptance criteria and detailed study results as commonly found in clinical trials for new drugs or high-risk devices are typically not presented in this format. Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This means showing that the new device is as safe and effective as a device already on the market, rather than proving its absolute safety and effectiveness through extensive clinical trials.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing, based on the nature of a 510(k) submission:

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

Acceptance Criteria: Not explicitly stated as pass/fail criteria for specific performance metrics in a table. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as well and is as safe as the predicate.
Reported Device Performance: Instead of performance criteria, the document provides a comparative table of technological characteristics between the E-Fit EF-1280 and its predicate device, Compex Sport (K011880). This comparison serves as the "performance" demonstration in a substantial equivalence context.

Parameter/Application	E-Fit EF-1280	Compex Sport (K011880)
Powered Muscle Stimulator	YES	YES
Regulated	YES	YES
Max Output Voltage @500Ω	36 V	48 V
Max Output Current @500Ω	72 mA	96.1 mA
Max Phase Charge @500Ω	36 µC	32.3 µC
Max Current Density @500Ω	0.85 mA/cm²	3.84 mA/cm²
Max Power Density @500Ω	6.3 mW/cm²	10.2 mW/cm²
Maximum Output Current	72 mA	120 mA
Maximum Output Voltage	0-36 V	0-135 V
Number of channels	1 output channel can shift in time to 12 outputs; current regulated individually on every output	4 independent channels; current regulated individually
Waveform	Symmetric biphasic	Symmetric biphasic
Output frequency	5-120 Hz	5-120 Hz
Positive pulse width	100-500 µsec	50-400 µsec
Negative pulse width	100-500 µsec	50-400 µsec
Number of programs	5+5	4+5
Program duration	Maximum 30 min	Maximum 60 min
Power source - Battery	12V (3.4Ah) lead Acid	7.2V (1.2Ah) NIMH battery
Size of the electrodes	Pre-defined (supplied with device) size and correct position	Choice of size, connection, and positioning by user
User interface	Rotary encoder, push button capability, large START/STOP and POWER off buttons, pictographs, fixed electrodes in clothing	Complex menu, slow integrated buttons, one button for multiple functions
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	No load trip, onload trip, battery monitoring
Portability/Mobile Use	Portable with difficulty, no mobile device, requires qualified and trained operator	Small, portable device (pocket size)
Material of the enclosure	Stainless steel	Plastic
Intended use	Stimulate healthy muscles to improve/facilitate muscle performance	Stimulate healthy muscles to improve/facilitate muscle performance
Operator	Certified persons (training required by seller)	Anyone can purchase and use
Menu / Settings	Simple one-level menu system	More levels/sub-menus, complex menu system
Plugs	Cables connect to electrodes with snap fastener, to machine with plastic 12-pin waterproof ip68 connector	Cables connect to electrodes with snap fastener, to machine with 4 similar plastic 2-pin connectors (risk of undefined channel control)
Lead wires - cables	SIFF 1-1.5mm2 (1x375 unique filaments) ultra flexible - Compliant with protected lead wire and patient cable safety requirements	CU 0.2mm2 (1x50 unique filaments) partly flexible - Compliant with protected lead wire and patient cable safety requirements
Conductivity of the electrodes	100% hygroscopic cotton underwear soaked with tap water, in contact with electrodes. Small conductive pads are washable and disinfectable.	Limited usage, gel-covered electrodes. Quality depends on user's skin type.
Soldering of the Printed Circuit Boards	According to ROHS directive (no lead solder)	Lead soldering solutions
Placement of the electrodes	Appropriately pre-placed in specific areas according to muscle anatomy	Self-Adhesive on any area of body
Reusable pads	YES	YES
Display	LCD 2x40 character LCD display with LED backlight	LCD graphical display
Statistical functions	Counting hours of operation	NO

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

Not Applicable / Not Provided: The document does not describe a clinical performance test set or data provenance in the way a clinical study would. The submission relies on a comparison of technical specifications and adherence to recognized standards to demonstrate safety and effectiveness.

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)

Not Applicable / Not Provided: No expert-established ground truth is mentioned, as there isn't a performance study evaluating diagnostic accuracy or similar metrics.

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

Not Applicable / Not Provided: No adjudication method is mentioned, as there isn't a performance study involving human interpretation that would require such a process.

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

Not Applicable / Not Provided: This device is a muscle stimulator, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study is not relevant to this submission.

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

Not Applicable / Not Provided: This device is a physical muscle stimulator, not an algorithm, so a standalone algorithmic performance study is not relevant.

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

Not Applicable / Not Provided: Ground truth for training or testing is not applicable due to the nature of the device and the substantial equivalence submission process.

8. The sample size for the training set

Not Applicable / Not Provided: There is no mention of a training set as this is not an AI/machine learning device.

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

Not Applicable / Not Provided: See point 8.

Summary of the Study per the Document:

The "study" presented is a 510(k) Premarket Notification, which is a regulatory submission, not a research study in the traditional sense. It aims to demonstrate substantial equivalence to an existing legally marketed device (the predicate device: Compex Sport, K011880).

The demonstration of substantial equivalence is based on:

Comparison of Intended Use: Both devices are intended to stimulate healthy muscles to improve/facilitate muscle performance.
Comparison of Technological Characteristics: A detailed table comparing various parameters (output voltage/current, pulse characteristics, programs, safety features, operator requirements, etc.) is provided. The submitter argues that differences do not raise new issues of safety or effectiveness.
Adherence to Recognized Standards: The E-Fit EF-1280 is designed and manufactured in accordance with several international standards (EN ISO 14971:2012, EN ISO 13485:2003 /AC2009, IEC 60601-1:2005 3rd edition, IEC 60601-1-2:2007, IEC 60601-1-11:2010, IEC 60601-2-10:2012). Software verification was done according to FDA guidance.

The conclusion is that based on the comparison of intended use, design, materials, and performance, the new device is substantially equivalent to the predicate in all aspects impacting safety and effectiveness, and the differences do not raise new issues of safety or effectiveness.

Summary

{0}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2014

Fit-Pro KFT Ltd. C/O Ms. Rhonda Alexander Senior Regulatory Specialist Registrar Corporation Medical Device Division 144 Research Drive Hampton, VA 23666

Re: K133225

Trade Name: E-Fit EF-1280 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX. GXY Dated: September 23, 2014 Received: September 25, 2014

Dear Ms. Alexander:

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. 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

{1}------------------------------------------------

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510/k) Number (if known) K133225

Device Name E-Fit EF-1280

Indications for Use (Describe)

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

중 40 - 10 - 10 - 2017 - 10:40 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 -

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

IN ON FOR FOR FOR FOR FOR THE CHINA CHICK CHANGE OF CHARA

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 lime 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,"

,在上一

{3}------------------------------------------------

510(k) SUMMARY (21 CFR 807.92)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

The assigned 510(k) number is:

Premarket Notification [510(k)] Summary

A. General Information

B. Submitter's Name:	FIT PRO, LLC
Address:	Sztregova Utca 22-28Budapest, Pest 1116Hungary
Telephone:	+36-30-477-2460
Contact Person:	Janos Papp, Managing Director
Date Prepared:	17 June 2013

C. Device

Trade Name:	E-Fit EF-1280
Common Name:	Stimulator, Muscle, Powered
Product Code:	NGX
Class:	2
Regulation Number:	21 CFR 890.5850

D. Identification of Legally Marketed Predicate Device

The following predicate device has been identified: Name: Compex Sport Manufacturer: Compex S.A. K Number: K011880

E. Description of the Device

F. Intended Use

The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit EF-1280 is not intended to be used in conjunction with

{4}------------------------------------------------

therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit EF-1280 training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The E-Fit EF-1280 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 EF-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF-1280 may therefore be considered a technique of muscle training.

Parameter/application	E-Fit EF-1280	Compex Sport(K011880)
Powered MuscleStimulator	YES	YES
Regulated	YES	YES
	Max Output Voltage = 36	Max Output Voltage = 48 V
	V @500Ω	@500Ω
Output specificationaccording the BasicUnit characteristicsdocument	Max Output Current = 72	Max Output Current = 96,1
	mA @500Ω	mA @500Ω
	Max Phase Charge = 36μC	Max Phase Charge = 32,3μC
	@500Ω	@500Ω
	Max Current Density =	Max Current Density =
	0,85mA/cm2 @500Ω	3,84mA/cm2 @500Ω
	Max Power Density =	Max Power Density =
	6,3mW/cm2 @500Ω	10,2mW/cm2 @500Ω
Maximum OutputCurrent	72 mA	120 mA
Maximum OutputVoltage	0-36V	0-135V

G. Technology characteristics

{5}------------------------------------------------

Number of channels	1 output channel can shiftin time to the 12 outputsbut electrical current canbe regulated individuallyon every outputs	4 independent channelswhich electrical current canbe regulated individually
Waveform	symmetric biphasic	symmetric biphasic
Output frequency	5-120Hz	5-120Hz
Positive pulse width	100-500usec	50-400usec
Negative pulse width	100-500usec	50-400usec
Number of programs	5+5	4+5
Program duration	Maximum 30 min	Maximum 60 min
Power source -Battery	12V (3,4Ah) lead Acid	7,2V (1,2Ah) NIMH battery
Size of the electrodes	Electrodes withpre-defined (supplied withthe device) size andcorrect position.	The choice of the size, theconnection andthe correct positioning ofthe electrodes areessential factors forensuring effective andcomfortable stimulation. Sothey requireparticular care.
User interface	The rotary encoder allowsfor a quick set-up andbecause of the pushbutton capability, theprogram can be stoppedimmediately for everychannel. There are largeSTART/STOP and POWERoff buttons to begin theprogram and for completepower shutdown. Becauseof the pictographs andfixed electrodes in theclothing, it is very easy to	The menu is complicatedbecause of the slowintegrated buttons. Onebutton is responsible formore than one function andoptions.
	set the appropriatemuscle groups.
Safety circuits	short-circuit monitoring,watchdog monitoring,no load trip, onload trip,battery monitoring,battery voltagemonitoring, outputcurrent monitoring(emergency STOP option),option for self test,hardware errormonitoring	no load trip, onload trip,battery monitoring
Portability/MobileUse	Portable with difficulty, nomobile device, itsintended use requires thequalified and trainedoperator.	Small, portable device(pocket size)
Material of theenclosure	stainless steel	plastic
Intended use	EF 1280 is intended tostimulate healthy musclesin order to improve orfacilitate muscleperformance.	Compex Sport (K011880) isintended to stimulatehealthy muscles in order toimprove or facilitate muscleperformance.
Operator	By manufacturerecommendations, theonly person who canoperate the device mustobtain certificationsprovided by the seller.This person mustcomplete the certificationprior to use on a patient.	Anyone can purchase anduse the device onthemselves with notechnical assistance orsecurity.
Menu / Settings	simple one-level menusystem	more levels/sub-menus,complex menu system
Plugs	cables connect to theelectrodes with snapfastener and connect tothe machine with plastic12pin waterproof ip68connector.	cables connect to theelectrodes with snapfastener and connect to themachine with 4 similarplastic 2pin connector. thesimilar interchangeableconnectors are increase therisk of undefined channelcontrol
Lead wires - cables	SIFF 1-1.5mm2 (1x375unique filaments)ultraflexible - Compliant withprotected lead wire andpatient cable safetyrequirements	CU 0,2mm2 (1x50 uniquefilaments ) partly flexible -Compliant with protectedlead wire and patient cablesafety requirements
Conductivity of theelectrodes	The subject needs to puton an 100% hygroscopiccotton underwear(surgery textile,biocompatibility certified)and these underwearneeds 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	Limited usage, gel-coveredelectrodes. After someusage, the quality of theelectrodes, resistance andadherence will depend onthe user's skin type.

	case the pulsetransmission efficiencywill not decrease. Thesmall conductive pads arewashable and disinfectable.
Soldering of thePrinted Circuit Boards	According to the ROHSdirective there is no leadsolder material used	Lead soldering solutions
Placement of theelectrodes	Appropriately pre-placedin specific areas accordingto muscle anatomy.	Self-Adhesive on any area ofbody.
Reusable pads	YES	YES
Display	LCD 2x40 character LCDdisplay with LED backlight	LCD graphical display
Statistical functions	statistical functions -counting the hours ofoperation	NO

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

None of the differences presented above impact the equivalence of the subject device when compared to the predicate device.

H. Summary of Testing and Comparison to the Predicate Device

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

. EN ISO 14971:2012
EN ISO 13485:2003 /AC2009 .
. IEC 60601-1:2005 3" edition
IEC 60601-1-2:2007 .
. IEC 60601-1-11:2010
. IEC 60601-2-10:2012

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

Compared the E-Fit EF 1280 to the predicate device, Compex Sport (K011880) it can be established that the E-Fit EF-1280 is similar in intended use, performance, design,

{10}------------------------------------------------

dimensions, and materials as the predicate device. The new device meets the same standards for safety as the predicate device.

l. Conclusion of Substantial Equivalence

Based on the comparison of intended use, design, materials and performance we conclude that the new device is substantially equivalent to the predicate devices in all aspects impacting on safety and effectiveness.

The differences that exist between the devices do not raise new issues of safety or effectiveness.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).