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 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.

AI/ML Overview

This document is an FDA 510(k) summary for a powered muscle stimulator called "WIEMSPRO." It's a regulatory submission, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance results from a study, sample sizes, expert ground truth establishment, or clinical study details.

The document explicitly states:

"No clinical studies provided."
"We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE):"
- "0. General information of both devices is the same"
- "1. Intended use and indications/principle of operations of both devices are the same."
- "2. There are no differences in the technological characteristic/performance data of the proposed device and those of the predicate device. Thus, the SE is not affected."
The comparison table (pages 4-5) lists technical specifications and notes "Same" for almost all characteristics between the original WIEMSPRO (K181955) and the "Modified Device" WIEMSPRO (K211298), except for the software version which is "Similar."

This 510(k) submission relies on demonstrating substantial equivalence to a previously cleared predicate device (K181955) by showing that the new device has the same intended use, indications for use, and similar technological characteristics, and that any minor differences do not raise new questions of safety or effectiveness. It does not present new performance data from a specific study designed to meet acceptance criteria through statistical testing.

Therefore, it's not possible to fill out the requested table or answer the questions based on the provided text, as this type of information is typically found in a clinical study report or a different section of a more comprehensive 510(k) submission if new performance data were required.

Summary

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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 (1-800-638-2041 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)

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)

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510(k) Summary

DATE OF SUBMISSION:DATE PREPARED:SUBMITTER NAME:SUBMITTER ADDRESS:	2021-03-182021-03-18Medical Cables, S.L.Calle Ferrocarril del Puerto 18 - Oficina 3-429002, MalagaSPAIN
CONTACT:TELEPHONE:	José Fuertes Peña+34 95 221 89 91
e-mail:	jfuertes@medicalcables.eu
DEVICE TRADE NAME:COMMON NAME:CLASSIFICATION NAME:	WIEMSPROPowered muscle stimulator.Stimulator, Muscle, Powered, For Muscle Conditioning(21 CFR 890.5850)
PREDICATE DEVICE(S):	WIEMSPRO (K181955)

DEVICE DESCRIPTION:

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 /Feature	CLEARED DEVICEWIEMSPRO	MODIFIED DEVICEWIEMSPRO	Comparison
	GENERAL COMPARISON
Classificationname	Powered muscle stimulator	Powered muscle stimulator	Same
Product code	NGX	NGX	Same
Regulationnumber	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 foruse	WIEMSPRO is intended to stimulate healthymuscles in order to improve or facilitatemuscle performance. The WIEMSPRO isnot intended to be used in conjunction withtherapy or treatment of medical diseases ormedical conditions of any kind. None ofWIEMSPRO training programs is designedfor injured or ailing muscles and its use onsuch muscles is contraindicated.WIEMSPRO is a machine with electronicmuscle stimulation based on EMStechnology. Regarding its use, the device isspecifically designed as an addition to othersports and for training muscles. It must beused for only healthy muscles and clients,not for rehabilitation purposes.WIEMSPRO electrical impulses allow thetriggering of action potentials onmotoneurones of motor nerves (excitations).These excitations of motoneurones aretransmitted to the muscle fibers via the motorendplate where they generate mechanicalmuscle fiber responses that correspond tomuscle work. Depending on the parametersof the electrical impulses (pulse frequency,duration of contraction, duration of rest, totalsession duration), different types of musclework can be imposed on the stimulatedmuscles.	WIEMSPRO is intended to stimulate healthymuscles in order to improve or facilitatemuscle performance. The WIEMSPRO isnot intended to be used in conjunction withtherapy or treatment of medical diseases ormedical conditions of any kind. None ofWIEMSPRO training programs is designedfor injured or ailing muscles and its use onsuch muscles is contraindicated.WIEMSPRO is a machine with electronicmuscle stimulation based on EMStechnology. Regarding its use, the deviceisspecifically designed as an addition toothersports and for training muscles. It must beused for only healthy muscles and clients,not for rehabilitation purposes.WIEMSPRO electrical impulses allow thetriggering of action potentials onmotoneurones of motor nerves(excitations). These excitations ofmotoneurones are transmitted to the musclefibers via the motor endplate where theygenerate mechanical muscle fiberresponses that correspond to muscle work.Depending on the parameters of theelectrical impulses (pulse frequency,duration of contraction, duration of rest, totalsession duration), different types of musclework can be imposed on the stimulatedmuscles.	Same
Intended use	Must be used for only healthy muscles andclient. It is not intended to be used inconjunction with therapy or treatment ofmedical diseases or medical conditions of	Must be used for only healthy muscles andclient. It is not intended to be used inconjunction with therapy or treatment ofmedical diseases or medical conditions of	Same
	any kind.It is designed to be used together with aWIEMSPRO Mobile Application.	any kind.It is designed to be used together with aWIEMSPRO Mobile Application.
	TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
PoweredMuscleStimulator	YES	YES	Same
Power Source	Non-removable lithium polymer batteryBattery: 3.7 V - 2,4AH (LiPo)	Non-removable lithium polymer batteryBattery: 3.7 V - 2,4AH (LiPo)	Same
Method of linecurrentisolation	N/A (battery operated device)	N/A (battery operated device)	Same
Patient leakagecurrent-Normalcondition	N/A (battery operated device)	N/A (battery operated device)	Same
-Single faultcondition	N/A (battery operated device)	N/A (battery operated device)	Same
Batteryoperated	YES	YES	Same
Number ofoutput modes	One output mode, but with varyingstimulation frequency and duty cycleranges.	One output mode, but with varyingstimulation frequency and duty cycleranges.	Same
Regulatedcurrent orregulatedvoltage?	YES, regulated current	YES, regulated current	Same
AutomaticOverload Trip?	YES	YES	Same
Automatic No-Load Trip?	YES	YES	Same
Automatic ShutOff ?	On/Off switch	On/Off switch	Same
Patient OverrideControl?	Yes, push on On/Off button directly pausethe program	Yes, push on On/Off button directly pausethe program	Same
Indicatordisplay	Yes	Yes	Same
Device weight	300 g	300 g	Same
Dimensions (in.)[W x H x D]	[6,66 x 3,27 x 1,18] in	[6,66 x 3,27 x 1,18] in	Same
Waveform (e.g.,pulsedmonophasic,biphasic)(program perprogram)	Symmetrical biphasic (all programs)	Symmetrical biphasic (all programs)	Same
Number ofprograms	20	20	Same
Current /Voltage	125mA/62.5V	125mA/62.5V	Same
Plastic HousingMaterials	PLASTIC	PLASTIC	Same
Maximumoutput voltage	170V	170V	Same
Maximumoutput current	125mA	125mA	Same
Maximumincrement inoutput current	Limited to increments of 15% in steps of one mA	Limited to increments of 15% in steps of one mA	Same
Maximumpower density	9,61mW/cm2@500ohm	9,61mW/cm2@500ohm	Same
Maximumcurrent density	1,92mA/cm2Smallest electrode size: 65 cm 2	1,92mA/cm2Smallest electrode size: 65 cm 2	Same
Number ofOutputchannels	1 CHANNEL	1 CHANNEL	Same
Independentchannels withpossibility toregulate thecurrentindividually	10 CHANNELS	10 CHANNELS	Same
Pulse duration(width)	100-400usec	100-400usec	Same
Frequency	1-100 HZ	1-100 HZ	Same
Reusable pads	YES	YES	Same
Software/Firmware/Microprocessor Control?	YES, Stimulator Software Ver 01	YES, Stimulator Software Ver 02	Similar
Compliancewith voluntarystandards / LABtests performed	IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006ISO 14971:2007ANSI/AAMI ES60601-1: 2005 /A2:2010	IEC 60601-1-2: 2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006ISO 14971:2007ANSI/AAMI ES60601-1: 2005 /A2:2010	Same

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wiemspro

510(k) Summary

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The difference presented above do not impact the equivalence of the subject device when compared to the predicate devices.

INTENDED USE:

Same as the predicate device.

SUMMARY DISCUSSION OF NON-CLINICAL DATA:

Same as the predicate device.

SUMMARY DISCUSSION OF CLINICAL DATA:

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510(k) Summary

Same as the predicate device. No clinical studies provided.

CONCLUSIONS:

We believe the intended use, the indications for use and principle of operation of WIEMSPRO are the same as the intended use, indications for use and performance of the predicate device.

We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE):

1. General information of both devices is the same
1. Intended use and indications/principle of operations of both devices are the same.
1. There are no differences in the technological characteristic/performance data of the proposed device and those of the predicate device. Thus, the SE is notaffected.

Based on the information provided in this premarket notification, Medical Cables, S.L. concludes that Cleared WIEMSPRO is substantially equivalent to the WIEMSPRO device with regard to safety and effectiveness.

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).