K Number

Device Name

WiEMSpro

Manufacturer

Medical Cables S.L.

Date Cleared

2022-08-25

(484 days)

Product Code

NGX

Regulation Number

890.5850

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181955

Reference Devices

K181955

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard EMS device and does not mention any AI or ML capabilities.

Therapeutic

No
The device explicitly states it is not intended for therapy or treatment of medical conditions and is not for rehabilitation purposes.

Diagnostic

No
The device is described as intended to stimulate healthy muscles to improve performance, not to diagnose medical conditions. It explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."

SaMD (Software as a Medical Device)

The device description explicitly states it is an "electro-medical device" and a "machine with electronic muscle stimulation based on EMS technology," indicating it includes hardware components for electrical stimulation.

IVD (In Vitro Diagnostic)

Based on the provided information, the WIEMSPRO device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
WIEMSPRO's Intended Use: The WIEMSPRO is clearly described as a device that stimulates healthy muscles externally using electrical impulses. It does not involve the analysis of any biological specimens.
Focus on Muscle Performance: The intended use and device description consistently state that the device is for improving or facilitating muscle performance in healthy individuals, not for diagnosing or monitoring medical conditions through the analysis of samples.

Therefore, the WIEMSPRO falls under the category of an electro-medical device for external muscle stimulation, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NGX

Device Description

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.

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

Not Found

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)

No clinical studies provided.

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

Not Found

Predicate Device(s)

K181955

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

Image /page/0/Picture/2 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

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

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: | 2021-03-18
2021-03-18
Medical Cables, S.L.
Calle Ferrocarril del Puerto 18 - Oficina 3-4
29002, Malaga
SPAIN |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT:
TELEPHONE: | José Fuertes Peña
+34 95 221 89 91 |
| e-mail: | jfuertes@medicalcables.eu |
| DEVICE TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME: | WIEMSPRO
Powered 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) -

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 DEVICE
WIEMSPRO	MODIFIED DEVICE
WIEMSPRO	Comparison
	GENERAL COMPARISON
Classification
name	Powered muscle stimulator	Powered muscle stimulator	Same
Product code	NGX	NGX	Same
Regulation
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
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 diseases or
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 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 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.	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 diseases or
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 its use, the deviceis
specifically designed as an addition toother
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 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.	Same
Intended use	Must be used for only healthy muscles and
client. It is not intended to be used in
conjunction with therapy or treatment of
medical diseases or medical conditions of	Must be used for only healthy muscles and
client. It is not intended to be used in
conjunction with therapy or treatment of
medical diseases or medical conditions of	Same
	any kind.
It is designed to be used together with a
WIEMSPRO Mobile Application.	any kind.
It is designed to be used together with a
WIEMSPRO Mobile Application.
	TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
Powered
Muscle
Stimulator	YES	YES	Same
Power Source	Non-removable lithium polymer battery
Battery: 3.7 V - 2,4AH (LiPo)	Non-removable lithium polymer battery
Battery: 3.7 V - 2,4AH (LiPo)	Same
Method of line
current
isolation	N/A (battery operated device)	N/A (battery operated device)	Same
Patient leakage
current
-Normal
condition	N/A (battery operated device)	N/A (battery operated device)	Same
-Single fault
condition	N/A (battery operated device)	N/A (battery operated device)	Same
Battery
operated	YES	YES	Same
Number of
output modes	One output mode, but with varying
stimulation frequency and duty cycle
ranges.	One output mode, but with varying
stimulation frequency and duty cycle
ranges.	Same
Regulated
current or
regulated
voltage?	YES, regulated current	YES, regulated current	Same
Automatic
Overload Trip?	YES	YES	Same
Automatic No-
Load Trip?	YES	YES	Same
Automatic Shut
Off ?	On/Off switch	On/Off switch	Same
Patient Override
Control?	Yes, push on On/Off button directly pause
the program	Yes, push on On/Off button directly pause
the program	Same
Indicator
display	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.,
pulsed
monophasic,
biphasic)
(program per
program)	Symmetrical biphasic (all programs)	Symmetrical biphasic (all programs)	Same
Number of
programs	20	20	Same
Current /
Voltage	125mA/62.5V	125mA/62.5V	Same
Plastic Housing
Materials	PLASTIC	PLASTIC	Same
Maximum
output voltage	170V	170V	Same
Maximum
output current	125mA	125mA	Same
Maximum
increment in
output current	Limited to increments of 15% in steps of one mA	Limited to increments of 15% in steps of one mA	Same
Maximum
power density	9,61mW/cm2@500ohm	9,61mW/cm2@500ohm	Same
Maximum
current density	1,92mA/cm2
Smallest electrode size: 65 cm 2	1,92mA/cm2
Smallest electrode size: 65 cm 2	Same
Number of
Output
channels	1 CHANNEL	1 CHANNEL	Same
Independent
channels with
possibility to
regulate the
current
individually	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/Firmw
are/Microproces
sor Control?	YES, Stimulator Software Ver 01	YES, Stimulator Software Ver 02	Similar
Compliance
with voluntary
standards / LAB
tests performed	IEC 60601-1-2:2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006
ISO 14971:2007
ANSI/AAMI ES60601-1: 2005 /
A2:2010	IEC 60601-1-2: 2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006
ISO 14971:2007
ANSI/AAMI ES60601-1: 2005 /
A2:2010	Same

wiemspro

510(k) Summary

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:

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.