WiEMSpro

K211298 · Medical Cables S.L. · NGX · Aug 25, 2022 · Physical Medicine

Device Facts

• Record ID: K211298
• Device Name: WiEMSpro
• Applicant: Medical Cables S.L.
• Product Code: NGX · Physical Medicine
• Decision Date: Aug 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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 the 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 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. 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 of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

Device Story

WIEMSPRO is a powered muscle stimulator for healthy muscles; used as an adjunct to sports and training. Device delivers electrical impulses to trigger action potentials on motor nerves, generating mechanical muscle fiber responses. System consists of a stimulator unit and a mobile application. Operated by users in a non-clinical setting. Output parameters (pulse frequency, contraction/rest duration) are adjustable to impose different types of muscle work. Benefits include improved muscle performance. Device features 10 independent channels, 20 programs, and uses symmetrical biphasic waveforms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on non-clinical bench testing and comparison to the predicate device.

Technological Characteristics

Powered muscle stimulator; 3.7V 2.4Ah LiPo battery; 10 independent output channels; symmetrical biphasic waveform; 1-100 Hz frequency; 100-400usec pulse duration; 125mA/62.5V max output. Plastic housing. Standards: IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, FCC Part 15, IEC 62304, ISO 14971, ANSI/AAMI ES60601-1.

Indications for Use

Indicated for healthy individuals to improve or facilitate muscle performance via electronic muscle stimulation. Contraindicated for use on injured or ailing muscles and for rehabilitation purposes.

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

• WIEMSPRO (K181955)

Submission Summary (Full Text)

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August 25, 2022

Medical Cables S.L. José Fuertes Peña Manager Calle Ferrocarril del Puerto 18 - Oficina 3-4 Málaga, Málaga 29002 Spain

Re: K211298

Trade/Device Name: WIEMSPRO Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: Julv 7, 2022 Received: July 21, 2022

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211298

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 the 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 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.

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

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## 510(k) Summary

| DATE OF SUBMISSION:<br>DATE PREPARED:<br>SUBMITTER NAME:<br>SUBMITTER ADDRESS: | 2021-03-18<br>2021-03-18<br>Medical Cables, S.L.<br>Calle Ferrocarril del Puerto 18 - Oficina 3-4<br>29002, Malaga<br>SPAIN |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT:<br>TELEPHONE: | José Fuertes Peña<br>[phone] |
| e-mail: | [e-mail] |
| DEVICE TRADE NAME:<br>COMMON NAME:<br>CLASSIFICATION NAME: | WIEMSPRO<br>Powered muscle stimulator.<br>Stimulator, Muscle, Powered, For Muscle Conditioning<br>(21 CFR 890.5850) |
| PREDICATE DEVICE(S): | WIEMSPRO (K181955) |

### 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.

WIEMSPRO is a device with electronic muscle stimulation based on EMS technology. Reqarding 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 rehabilitationpurposes.

### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

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

> WIEMSPRO (K181955) -

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## 510(k) Summary

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

| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristic /<br>Feature | CLEARED DEVICE<br>WIEMSPRO | MODIFIED DEVICE<br>WIEMSPRO | Comparison |
| | GENERAL COMPARISON | | |
| Classification<br>name | Powered muscle stimulator | Powered muscle stimulator | Same |
| Product code | NGX | NGX | Same |
| Regulation<br>number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical Medicine | Physical Medicine | Same |
| Class | Class II | Class II | Same |
| 510(K) Number | K181955 | K211298 | N/A |
| | INTENDED USE | | |
| Indications for<br>use | WIEMSPRO is intended to stimulate healthy<br>muscles in order to improve or facilitate<br>muscle performance. The WIEMSPRO is<br>not intended to be used in conjunction with<br>therapy or treatment of medical diseases or<br>medical conditions of any kind. None of<br>WIEMSPRO training programs is designed<br>for injured or ailing muscles and its use on<br>such muscles is contraindicated.<br>WIEMSPRO is a machine with electronic<br>muscle stimulation based on EMS<br>technology. Regarding its use, the device is<br>specifically designed as an addition to other<br>sports and for training muscles. It must be<br>used for only healthy muscles and clients,<br>not for rehabilitation purposes.<br>WIEMSPRO electrical impulses allow the<br>triggering of action potentials on<br>motoneurones of motor nerves (excitations).<br>These excitations of motoneurones are<br>transmitted to the muscle fibers via the motor<br>endplate where they generate mechanical<br>muscle fiber responses that correspond to<br>muscle work. Depending on the parameters<br>of the electrical impulses (pulse frequency,<br>duration of contraction, duration of rest, total<br>session duration), different types of muscle<br>work can be imposed on the stimulated<br>muscles. | WIEMSPRO is intended to stimulate healthy<br>muscles in order to improve or facilitate<br>muscle performance. The WIEMSPRO is<br>not intended to be used in conjunction with<br>therapy or treatment of medical diseases or<br>medical conditions of any kind. None of<br>WIEMSPRO training programs is designed<br>for injured or ailing muscles and its use on<br>such muscles is contraindicated.<br>WIEMSPRO is a machine with electronic<br>muscle stimulation based on EMS<br>technology. Regarding its use, the deviceis<br>specifically designed as an addition toother<br>sports and for training muscles. It must be<br>used for only healthy muscles and clients,<br>not for rehabilitation purposes.<br>WIEMSPRO electrical impulses allow the<br>triggering of action potentials on<br>motoneurones of motor nerves<br>(excitations). These excitations of<br>motoneurones are transmitted to the muscle<br>fibers via the motor endplate where they<br>generate mechanical muscle fiber<br>responses that correspond to muscle work.<br>Depending on the parameters of the<br>electrical impulses (pulse frequency,<br>duration of contraction, duration of rest, total<br>session duration), different types of muscle<br>work can be imposed on the stimulated<br>muscles. | Same |
| Intended use | Must be used for only healthy muscles and<br>client. It is not intended to be used in<br>conjunction with therapy or treatment of<br>medical diseases or medical conditions of | Must be used for only healthy muscles and<br>client. It is not intended to be used in<br>conjunction with therapy or treatment of<br>medical diseases or medical conditions of | Same |
| | any kind.<br>It is designed to be used together with a<br>WIEMSPRO Mobile Application. | any kind.<br>It is designed to be used together with a<br>WIEMSPRO Mobile Application. | |
| | TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | | |
| Powered<br>Muscle<br>Stimulator | YES | YES | Same |
| Power Source | Non-removable lithium polymer battery<br>Battery: 3.7 V - 2,4AH (LiPo) | Non-removable lithium polymer battery<br>Battery: 3.7 V - 2,4AH (LiPo) | Same |
| Method of line<br>current<br>isolation | N/A (battery operated device) | N/A (battery operated device) | Same |
| Patient leakage<br>current<br>-Normal<br>condition | N/A (battery operated device) | N/A (battery operated device) | Same |
| -Single fault<br>condition | N/A (battery operated device) | N/A (battery operated device) | Same |
| Battery<br>operated | YES | YES | Same |
| Number of<br>output modes | One output mode, but with varying<br>stimulation frequency and duty cycle<br>ranges. | One output mode, but with varying<br>stimulation frequency and duty cycle<br>ranges. | Same |
| Regulated<br>current or<br>regulated<br>voltage? | YES, regulated current | YES, regulated current | Same |
| Automatic<br>Overload Trip? | YES | YES | Same |
| Automatic No-<br>Load Trip? | YES | YES | Same |
| Automatic Shut<br>Off ? | On/Off switch | On/Off switch | Same |
| Patient Override<br>Control? | Yes, push on On/Off button directly pause<br>the program…