E-FIT EF-1280 EMS MACHINE

K133225 · Fit-Pro Kft , Ltd. · NGX · Oct 24, 2014 · Physical Medicine

Device Facts

• Record ID: K133225
• Device Name: E-FIT EF-1280 EMS MACHINE
• Applicant: Fit-Pro Kft , Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Oct 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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 ailing muscles and its use on such muscles is contraindicated.

Device Story

E-Fit EF-1280 is a powered muscle stimulator using EMS technology; designed for healthy individuals as an adjunct to sports and muscle training. Device delivers electrical impulses to trigger action potentials on motor nerves; impulses transmitted to motor endplates to generate mechanical muscle fiber responses. Parameters (pulse frequency, contraction/rest duration) are adjustable to impose different types of muscle work. Operated by certified professionals in a clinical or training setting; user wears hygroscopic cotton underwear soaked in tap water to serve as conductive media for fixed electrodes. Output is controlled via rotary encoder and push buttons; system includes safety monitoring (short-circuit, watchdog, battery, current). Benefits include improved muscle performance through targeted training. Not for rehabilitation or medical treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10 standards, alongside software verification per FDA guidance.

Technological Characteristics

Powered muscle stimulator; stainless steel enclosure. Symmetric biphasic waveform; 5-120Hz frequency; 100-500usec pulse width. 12V lead-acid battery power. Conductive interface via water-soaked cotton underwear. Safety features: short-circuit, watchdog, no-load/on-load, battery, and output current monitoring. Standards: EN ISO 14971:2012, EN ISO 13485:2003, IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, IEC 60601-2-10:2012.

Indications for Use

Indicated for healthy muscles and clients to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles, or in conjunction with therapy or treatment of medical diseases or conditions.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Compex Sport (K011880)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510/k) Number (if known) K133225

Device Name E-Fit EF-1280

#### Indications for Use (Describe)

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.

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

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2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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 22-28<br>Budapest, Pest 1116<br>Hungary |
| Telephone: | [phone] |
| 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

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.

### F. Intended Use

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.

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

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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<br>(K011880) |
|---------------------------------------------------------------------------------|-------------------------|---------------------------|
| Powered Muscle<br>Stimulator | YES | YES |
| Regulated | YES | YES |
| | Max Output Voltage = 36 | Max Output Voltage = 48 V |
| | V @500Ω | @500Ω |
| Output specification<br>according the Basic<br>Unit characteristics<br>document | 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 Output<br>Current | 72 mA | 120 mA |
| Maximum Output<br>Voltage | 0-36V | 0-135V |

#### G. Technology characteristics

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| Number of channels | 1 output channel can shift<br>in time to the 12 outputs<br>but electrical current can<br>be regulated individually<br>on every outputs | 4 independent channels<br>which electrical current can<br>be 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 -<br>Battery | 12V (3,4Ah) lead Acid | 7,2V (1,2Ah) NIMH battery |
| Size of the electrodes | Electrodes with<br>pre-defined (supplied with<br>the device) size and<br>correct position. | The choice of the size, the<br>connection and<br>the correct positioning of<br>the electrodes are<br>essential factors for<br>ensuring effective and<br>comfortable stimulation. So<br>they require<br>particular care. |
| User interface | The rotary encoder allows<br>for a quick set-up and<br>because of the push<br>button capability, the<br>program can be stopped<br>immediately for every<br>channel. There are large<br>START/STOP and POWER<br>off buttons to begin the<br>program and for complete<br>power shutdown. Because<br>of the pictographs and<br>fixed electrodes in the<br>clothing, it is very easy to | The menu is complicated<br>because of the slow<br>integrated buttons. One<br>button is responsible for<br>more than one function and<br>options. |
| | set the appropriate<br>muscle groups. | |
| Safety circuits | short-circuit monitoring,<br>watchdog monitoring,<br>no load trip, onload trip,<br>battery monitoring,<br>battery voltage<br>monitoring, output<br>current monitoring<br>(emergency STOP option),<br>option for self test,<br>hardware error<br>monitoring | no load trip, onload trip,<br>battery monitoring |
| Portability/Mobile<br>Use | Portable with difficulty, no<br>mobile device, its<br>intended use requires the<br>qualified and trained<br>operator. | Small, portable device<br>(pocket size) |
| Material of the<br>enclosure | stainless steel | plastic |
| Intended use | EF 1280 is intended to<br>stimulate healthy muscles<br>in order to improve or<br>facilitate muscle<br>performance. | Compex Sport (K011880) is<br>intended to stimulate<br>healthy muscles in order to<br>improve or facilitate muscle<br>performance. |
| Operator | By manufacture<br>recommendations, the<br>only person who can<br>operate the device must<br>obtain certifications<br>provided by the seller.<br>This person must<br>complete the certification<br>prior to use on a patient. | Anyone can purchase and<br>use the device on<br>themselves with no<br>technical assistance or<br>security. |
| Menu / Settings | simple one-level menu<br>system | more levels/sub-menus,<br>complex menu system |
| Plugs | cables connect to the<br>electrodes with snap<br>fastener and connect to<br>the machine with plastic<br>12pin waterproof ip68<br>connector. | cables connect to the<br>electrodes with snap<br>fastener and connect to the<br>machine with 4 similar<br>plastic 2pin connector. the<br>similar interchangeable<br>connectors are increase the<br>risk of undefined channel<br>control |
| Lead wires - cables | SIFF 1-1.5mm2 (1x375<br>unique filaments)ultra<br>flexible - Compliant with<br>protected lead wire and<br>patient cable safety<br>requirements | CU 0,2mm2 (1x50 unique<br>filaments ) partly flexible -<br>Compliant with protected<br>lead wire and patient cable<br>safety requirements |
| Conductivity of the<br>electrodes | The subject needs to put<br>on an 100% hygroscopic<br>cotton underwear<br>(surgery textile,<br>biocompatibility certified)<br>and these underwear<br>needs to be<br>soaked/irrigated with<br>normal tap water. So the<br>electro conductive media<br>is simply tap watered<br>cotton which is in contact<br>with the electrodes. The<br>surface of the electrode<br>will not get dry. In this | Limited usage, gel-covered<br>electrodes. After some<br>usage, the quality of the<br>electrodes, resistance and<br>adherence will depend on<br>the user's skin type. |
| | | |
| | case the pulse<br>transmission efficiency<br>will not decrease. The<br>small conductive pads are<br>washable and disinfect<br>able. | |
| Soldering of the<br>Printed Circuit Boards | According to the ROHS<br>directive there is no lead<br>solder material used | Lead soldering solutions |
| Placement of the<br>electrodes | Appropriately pre-placed<br>in specific areas according<br>to muscle anatomy. | Self-Adhesive on any area of<br>body. |
| Reusable pads | YES | YES |
| Display | LCD 2x40 character LCD<br>display with LED backlight | LCD graphical display |
| Statistical functions | statistical functions -<br>counting the hours of<br>operation | NO |

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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,

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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.