WiEMSpro

K181955 · Medical Cables S.L. · NGX · Feb 12, 2019 · Physical Medicine

Device Facts

• Record ID: K181955
• Device Name: WiEMSpro
• Applicant: Medical Cables S.L.
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding 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. WIEMSPRO 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, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

Device Story

WIEMSPRO is an electro-medical device for electronic muscle stimulation (EMS) used for fitness and muscle training. It delivers electrical impulses to trigger action potentials on motor nerves, causing mechanical muscle fiber responses. The device is designed for use on healthy muscles only and is not intended for rehabilitation. It is used in conjunction with a mobile application. The system is worn over cotton undergarments, avoiding direct patient contact. The device is battery-operated (3.7V LiPo) and features 10 channels. It is not intended for use while the user is in motion or lifting weights. The healthcare provider or user selects stimulation parameters (frequency, pulse duration, rest duration) to impose specific types of muscle work, aiming to improve muscle performance.

Clinical Evidence

Bench testing only. No clinical studies were submitted. Performance was verified through electrical safety, electromagnetic compatibility, and FCC radio frequency testing.

Technological Characteristics

Powered muscle stimulator; battery-operated (3.7V LiPo); 10 output channels; symmetrical biphasic waveform; frequency 1-100 Hz; pulse duration 100-400 µsec; max output 125mA/62.5V; max current density 1.92 mA/cm². Complies with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-6, IEC 62304, ISO 14971, and ANSI/AAMI ES60601-1.

Indications for Use

Indicated for healthy adults to stimulate muscles to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles, or for rehabilitation, therapy, or treatment of any medical condition.

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)

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February 12, 2019

Medical Cables, S.L. José Fuertes Peña Manager Duque de la Victoria 6, 1º Malaga, Spain 29015

Re: K181955

Trade/Device Name: WIEMSPRO Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 18, 2018 Received: January 16, 2019

Dear José Fuertes Peña:

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.html; 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 J. Pinto -S

for Carlos L. Peña, PhD, MS 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) K181955

Device Name WIEMSPRO

#### Indications for Use (Describe)

WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding 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.

WIEMSPRO 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, duration, 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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Premarket medicalcables WIEMSpro Notification DATE OF SUBMISSION: 2018-03-02 SUBMITTER NAME: Medical Cables, S.L. SUBMITTER ADDRESS: Duque de la Victoria 6, 1º 29015, Malaga SPAIN CONTACT: José Fuertes Peña TELEPHONE: [phone] E-mail: [e-mail] DEVICE TRADE NAME: WIEMSpro COMMON NAME: Powered muscle stimulator. Stimulator, Muscle, Powered, For Muscle Conditioning CLASSIFICATION NAME: (21 CFR 890.5850) E-Fit EF-1280 (K133225) PREDICATE DEVICE(S): Compex Wireless USA (K170903)

#### DEVICE DESCRIPTION:

The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.

WIEMSero is a device 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 device must be used over user's cotton undergarments and is therefore not patient-contacting

WIEMSPRO system cannot be used while the user is in motion or lifting weights.

#### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

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

- E-Fit EF-1280 (K133225) -
- Compex WirelessUSA (K170903) -

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# 510(k) Premarket Notification

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

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