Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electronic muscle stimulation (EMS) device and makes no mention of AI or ML technologies.

Therapeutic

No
The device is specifically stated as not being intended for rehabilitation, therapy, or treatment of medical diseases or conditions, but rather for stimulating healthy muscles to improve or facilitate muscle performance as a training technique.

Diagnostic

No

The device description explicitly states that the E-Fit EP-1280 is not intended for therapy, treatment of medical diseases or conditions, or rehabilitation purposes. Its use is limited to stimulating healthy muscles to improve performance, rather than diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "machine with electronic muscle stimulation based on EMS technology," indicating it is a hardware device that delivers electrical impulses.

IVD (In Vitro Diagnostic)

Based on the provided information, the E-Fit EP-1280 is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The E-Fit EP-1280 does not interact with or analyze any biological specimens.
The intended use of the E-Fit EP-1280 is for stimulating healthy muscles to improve or facilitate muscle performance. This is a physical intervention, not a diagnostic test.
The device description clearly states it's a machine with electronic muscle stimulation based on EMS technology. This technology directly interacts with the body's electrical signals to cause muscle contractions.

The E-Fit EP-1280 falls under the category of a physical therapy or exercise device, specifically an electrical muscle stimulator, intended for fitness and performance enhancement in healthy individuals.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

E-Fit EF-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.

Product codes

NGX, GXY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operator: By manufacture recommendations, the only person who can operate the device must obtain certifications provided by the seller. This person must complete the certification prior to use on a patient.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K011880

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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 (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

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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)

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)

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

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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
Budapest, Pest 1116
Hungary
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

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

G. Technology characteristics

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| Number of channels | 1 output channel can shift
in time to the 12 outputs
but electrical current can
be regulated individually
on every outputs | 4 independent channels
which electrical current can
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 -
Battery | 12V (3,4Ah) lead Acid | 7,2V (1,2Ah) NIMH battery |
| Size of the electrodes | Electrodes with
pre-defined (supplied with
the device) size and
correct position. | The choice of the size, the
connection and
the correct positioning of
the electrodes are
essential factors for
ensuring effective and
comfortable stimulation. So
they require
particular care. |
| User interface | 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 shutdown. Because
of the pictographs and
fixed electrodes in the
clothing, it is very easy to | The menu is complicated
because of the slow
integrated buttons. One
button is responsible for
more than one function and
options. |
| | set the appropriate
muscle groups. | |
| 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, its
intended use requires the
qualified and trained
operator. | Small, portable device
(pocket size) |
| Material of the
enclosure | stainless steel | plastic |
| Intended use | EF 1280 is intended to
stimulate healthy muscles
in order to improve or
facilitate muscle
performance. | Compex Sport (K011880) is
intended to stimulate
healthy muscles in order to
improve or facilitate muscle
performance. |
| Operator | By manufacture
recommendations, the
only person who can
operate the device must
obtain certifications
provided by the seller.
This person must
complete the certification
prior to use on a patient. | Anyone can purchase and
use the device on
themselves with no
technical assistance or
security. |
| Menu / Settings | simple one-level menu
system | more levels/sub-menus,
complex menu system |
| Plugs | cables connect to the
electrodes with snap
fastener and connect to
the machine with plastic
12pin waterproof ip68
connector. | cables connect to the
electrodes with snap
fastener and connect to the
machine with 4 similar
plastic 2pin connector. the
similar interchangeable
connectors are increase the
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 | The subject needs to put
on an 100% hygroscopic
cotton underwear
(surgery textile,
biocompatibility certified)
and these underwear
needs to be
soaked/irrigated with
normal tap water. So the
electro conductive media
is simply tap watered
cotton which is in contact
with the electrodes. The
surface of the electrode
will not get dry. In this | Limited usage, gel-covered
electrodes. After some
usage, the quality of the
electrodes, resistance and
adherence will depend on
the user's skin type. |
| | | |
| | case the pulse
transmission efficiency
will not decrease. The
small conductive pads are
washable and disinfect
able. | |
| Soldering of the
Printed Circuit Boards | According to the ROHS
directive there is no lead
solder material used | 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 | statistical functions -
counting the hours of
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,

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.