FLIX-EMS

K181419 · Casgarum Investment, S.L. · NGX · May 14, 2019 · Physical Medicine

Device Facts

• Record ID: K181419
• Device Name: FLIX-EMS
• Applicant: Casgarum Investment, S.L.
• Product Code: NGX · Physical Medicine
• Decision Date: May 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 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.

Device Story

FLIX-EMS is a powered muscle stimulator for sports and fitness. It uses low-intensity electrical impulses to trigger action potentials on motor nerves, generating muscle contractions. The system comprises a suit with integrated electrodes, a main control unit, and a tablet/mobile app. The user wears a water-soaked cotton garment to ensure electrode conductivity. The app allows trainers to select and monitor stimulation programs, adjust power levels per channel, and track usage data via a cloud server. The device combines voluntary user movement with electrical stimulation to enhance workout effectiveness. It is intended for use in indoor athletic training facilities by specialized, certified trainers. The device provides symmetric biphasic waveforms to stimulate multiple muscle groups simultaneously. It benefits users by facilitating muscle conditioning and performance improvement.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (ANSI AAMI 60601-1), electromagnetic compatibility (IEC 60601-1-2), and FCC radio frequency testing.

Technological Characteristics

Powered muscle stimulator; symmetric biphasic waveform; 5-100 Hz frequency; 50-400 μs pulse width; 70mA/100V max output. Connectivity via Bluetooth to Android tablet/mobile app. Power source: 8.4V (3400mA) Li-ion battery. Electrodes integrated into suit; conductivity via water-soaked cotton garment. Standards: ANSI AAMI 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304.

Indications for Use

Indicated for healthy adult muscles to improve or facilitate muscle performance. Contraindicated for injured or disease-afflicted muscles; not for rehabilitation or physiotherapy.

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

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

Submission Summary (Full Text)

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

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.

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

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 ([e-mail]) or phone [phone] 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

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

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.

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

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.

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 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

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

#### 510(k) Premarket Notification

#### SECTION 05 - 510(k) Summary

| DATE OF SUBMISSION:<br>SUBMITTER NAME:<br>SUBMITTER ADDRESS: | 2018-04-19<br>CASGARUM INVESTMENT, S.L.<br>Calle Real, 17 B E<br>45200, Illescas<br>Toledo, Spain |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT:<br>TELEPHONE: | Rafael Castillo<br>[phone] |
| e-mail: | [e-mail] |
| DEVICE TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION NAME: | FLIX-EMS<br>STIMULATOR, MUSCLE, POWERED<br>Stimulator, muscle, powered, for muscle conditioning<br>(21 CFR 890.5850) |
| PREDICATE DEVICE(S): | E-Fit EF-1280 (K133225)<br>Compex Wireless USA (K170903) |

#### 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.

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

#### 510(k) Premarket Notification

#### SECTION 05 - 510(k) Summary

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.

#### 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 DEVICE<br>FLIX-EMS | PREDICATE DEVICE<br>E-Fit EF-1280 | PREDICATE DEVICE<br>Compex Wireless USA | Comparison |
| | GENERAL COMPARISON | | | |
| Classification name | Powered muscle<br>stimulator | Powered muscle<br>stimulator | Powered muscle<br>stimulator | 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 is<br>intended to stimulate<br>healthy muscles in order<br>to improve or facilitate<br>muscle performance. It<br>is to be used by adults<br>only.<br><br>FLIX-EMS is not | E-fit EF-1280 is a<br>machine with electronic<br>muscle stimulation<br>based on EMS<br>technology. Regarding<br>its use, the device is<br>specifically designed as<br>an addition to other<br>sports and for training | The Compex Wireless<br>USA is an Over-The-<br>Counter device intended<br>to stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle performance. It is<br>to be used by adults<br>only. | Same<br><br>FLIX-EMS does not<br>include TENS |
| Characteristic / Feature | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | Comparison |
| | PROPOSED DEVICE<br>FLIX-EMS | PREDICATE DEVICE<br>E-Fit EF-1280 | PREDICATE DEVICE<br>Compex Wireless USA | |
| | intended for adjunctive<br>therapy in the treatment<br>of medical diseases and<br>conditions of any kind.<br>None of the FLIX-EMS<br>stimulation programs<br>are designed for injured<br>or disease afflicted<br>muscles. Its use on<br>such muscles is<br>contraindicated. The<br>work imposed on the<br>muscles by the FLIX-<br>EMS programs is<br>definitely not suitable for<br>rehabilitation and<br>physiotherapy.<br>FLIX-EMS electrical<br>impulses allow the<br>triggering of action<br>potentials on<br>motoneurones of<br>motor nerves<br>(excitations).<br>These excitations of<br>motoneurones are<br>transmitted to the<br>muscle fibers via the<br>motor endplate where<br>they generate<br>mechanical muscle fiber<br>responses that<br>correspond to muscle<br>work. Depending on the<br>parameters of the<br>electrical impulses<br>(pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration),<br>different types of<br>muscle work can be<br>imposed on the<br>stimulated muscles | muscles. It must be<br>used for only healthy<br>muscles and clients,<br>not for rehabilitation<br>purposes.<br>The E-Fit EF-1280<br>intended to stimulate<br>healthy muscles in<br>order to improve or<br>facilitate muscle<br>performance.<br>The E-Fit EF-1280<br>is not intended<br>to be used in<br>conjunction with<br>therapy or treatment<br>of medical diseases<br>or medical conditions<br>of any kind.<br>None of the E-Fit EF-<br>1280 training programs<br>is designed for<br>injured or ailing<br>muscles and its use<br>on such muscles is<br>contraindicated.<br>The E-Fit EF-1280<br>electrical impulses<br>allow<br>the triggering of<br>action potentials on<br>motoneurones of<br>motor nerves<br>(excitations).<br>These excitations of<br>motoneurones are<br>transmitted to the<br>muscle fibers via the<br>motor endplate<br>where they generate<br>mechanical muscle<br>fiber responses that<br>correspond to muscle<br>work. Depending on<br>the parameters of<br>the electrical<br>impulses (pulse<br>frequency, duration<br>of contraction. | The Compex Wireless USA<br>is not intended for<br>adjunctive therapy in the<br>treatment of medical<br>diseases and conditions of<br>any kind. None of the<br>Compex Wireless USA<br>stimulation programs are<br>designed for injured or<br>disease afflicted muscles. Its<br>use on such muscles is<br>contraindicated. The work<br>imposed on the muscles by<br>the Compex Wireless USA<br>programs is definitely not<br>suitable for rehabilitation<br>and physiotherapy.<br>The Compex Wireless<br>USA electrical impulses<br>allow the triggering of<br>action potentials on<br>motoneurones of motor<br>nerves (excitations).<br>These excitations of<br>motoneurones are<br>transmitted to the muscle<br>fibers via the motor endplate<br>where they generate<br>mechanical muscle fiber<br>responses that correspond<br>to muscle work. Depending<br>on the parameters of the<br>electrical impulses (pulse<br>frequency, duration of<br>contraction, duration of rest,<br>total session duration),<br>different types of muscle<br>work can be imposed on the<br>stimulated muscles. The<br>Compex Wireless USA may<br>therefore be considered a<br>technique of muscle training.<br>The Compex Wireless<br>USA TENS is used for:<br>• temporary relief of pain | |
| | | frequency, duration<br>of contraction,<br>duration of rest, total | | |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | | Session duration), different<br>types of muscle work can<br>be imposed on the<br>stimulated muscles are able<br>to improve or facilitate<br>muscle performance.<br><br>The E-Fit EF-1280 may<br>therefore be considered<br>a technique of muscle<br>training. | associated with sore and<br>aching muscles due to<br>strain from exercise or<br>normal household and<br>work activities.<br>• the symptomatic relief<br>and management of<br>chronic, intractable pain<br>and relief of pain<br>associated with arthritis.…