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

I-MOTION 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.

I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, 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. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights.

AI/ML Overview

This document describes the I-Motion and I-Motion Fit powered muscle stimulators and their substantial equivalence to a predicate device (WIEMSpro, K181955). However, the provided text does not contain any information about a clinical study or performance data that would directly address acceptance criteria for a new AI/medical device, as typically seen in submissions requiring clinical validation (e.g., for diagnostic AI).

Instead, this is a 510(k) Premarket Notification summary for a Class II medical device (Powered Muscle Stimulator). For this type of device and submission, the primary method of demonstrating safety and effectiveness is through a comparison to a legally marketed predicate device and non-clinical testing (e.g., electrical safety, electromagnetic compatibility, functional tests). It explicitly states: "Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence." and "We did not use any new technology in this system...".

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device validation (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies) is largely not applicable to this specific submission as described.

However, I can extract and present the information that is available in the provided text, reinterpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on the comparison to the predicate device and the non-clinical testing.

Device Acceptance Criteria and Performance (Based on Substantial Equivalence to Predicate Device)

Given that this is a 510(k) summary for a powered muscle stimulator demonstrating substantial equivalence to a predicate device, the "acceptance criteria" are implicitly met by showing the new device is as safe and effective as the predicate. This is primarily established through a comparison of technological characteristics and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comprehensive comparison between the I-Motion device and its predicate, the WIEMSpro (K181955). The "acceptance criteria" in this context are the demonstrable similarities or non-significant differences in design, intended use, and performance parameters, alongside compliance with relevant safety standards.

Characteristic / Feature	Predicate Device (WIEMSpro)	Proposed Device (I-Motion)	Comparison and Performance against "Criteria" (Substantial Equivalence)
General Classification	Powered muscle stimulator (NGX, 21 CFR 890.5850, Class II)	Powered muscle stimulator (NGX, 21 CFR 890.5850, Class II)	Same: Meets the same regulatory classification, indicating similar fundamental characteristics and regulatory pathway.
Intended Use & Indications for Use	Stimulate healthy muscles to improve/facilitate muscle performance; not for therapy/treatment of medical conditions/ailing muscles. EMS technology, addition to other sports, training muscles.	Stimulate healthy muscles to improve/facilitate muscle performance; not for therapy/treatment of medical conditions/ailing muscles. EMS technology, addition to other sports, training muscles.	Same/Similar: The core intended use and indications are identical. Minor differences in software application are noted but deemed not to affect safety, efficiency, or functionality.
Prescription Use	Prescription only	Prescription only	Same: Both devices are prescription-only.
Use Environment	Use in athletic training facilities. Not for use outdoors.	Use in athletic training facilities. Not for use outdoors.	Same: Designed for the same operational environment.
Anatomical Sites	Electrodes can be applied to multiple anatomical sites.	Electrodes can be applied to multiple anatomical sites.	Same: Offers the same flexibility in application.
Power Source	Battery: 3.7V - 2.4AH (LiPo)	Battery: 2 x 3.7V = 7.4V - 3.4AH (Lithium)	Similar: Minimal differences in battery technical characteristics/performance, not affecting safety, efficiency, or functionality. Both are battery operated.
Current / Voltage	125mA / 62.5V	90mA / 45V	Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality.
Pulse Duration (Width)	100-400 µsec	150-450 µsec	Same: The specified ranges are overlapping or within an acceptable variation for similar function.
Frequency	1-100 Hz	1-100 Hz	Same: Identical frequency range.
Maximum Output Voltage	170V	110V	Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality.
Maximum Output Current	125mA	90mA	Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality.
Maximum Power Density	9.61mW/cm² @ 500ohm	9 mW/cm² @ 500ohm	Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality.
Electrode Type/Application	Silicone conductive electrodes; reusable. Never in direct contact with skin (cotton underwear used). 9 pairs, single muscle group. Sizes: 65 cm², 83 cm².	Conductive fabric, reusable electrodes (not in direct contact with skin). Cotton covers/garments used. 9 pairs, single muscle group. Sizes: 96 cm², 48 cm².	Same/Similar: Both use reusable electrodes not in direct skin contact, utilizing hygroscopic cotton underwear. Differences in exact electrode size are detailed but imply similar functional principle.
Connectivity	Lead wires, Stainless steel snap fastener	PIN 2 mm	Similar: Minimal differences in the technical characteristic/performance, not affecting the safety, efficiency, or functionality of the device.
Conductivity Medium	100% hygroscopic cotton underwear soaked/irrigated with normal tap water.	100% hygroscopic cotton underwear soaked/irrigated with normal tap water.	Same: Identical method for achieving conductivity, ensuring consistent and established safety/efficacy.
Software/Firmware/Microprocessor	Yes	Yes	Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. The difference is the software application controlling the device, which is stated to not affect safety, efficiency, or functionality.
Safety Features	Automatic Overload Trip (Yes), Automatic No-Load Trip (Yes), Automatic Shut Off (On/Off switch), Patient Override Control (Yes, push on On/Off button). Indicator displays (On/Off status, Low Battery, Voltage/Current level).	Automatic Overload Trip (Yes), Automatic No-Load Trip (Yes), Automatic Shut Off (On/Off switch), Patient Override Control (Yes, push on On/Off button). Indicator displays (On/Off status, Low Battery, Voltage/Current level).	Same: All critical safety features and indicators are identical.
Compliance with Standards / LAB tests performed	IEC 60601-1:2005, 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.	IEC 60601-1:2005 (ed. 3.0) + corrigendum 2006+ corrigendum 2007 + interpretation sheet 2008 + interpretation sheet 2009 + A1:2012, IEC 60601-1-6:2010 (ed.3.0) + A1:2013, IEC 60601-1-2-10:2010 (ed.2.0) + A1:2016, IEC 62304:2006, ISO 14971:2019.	Similar: All corresponding standard norms are complied with. Differences are due to updated versions of the norms, implying continued compliance with current safety and performance requirements.

Conclusion on "Performance": The document concludes that "None of the differences presented above impact the equivalence of the subject device when compared to the predicate devices." and "There are minimum differences in the technological characteristic/performance... nevertheless, all of them comply with IEC60601-1-2, IEC60601-2-10. Thus, the SE is not affected." This statement serves as the proof that the device "meets the acceptance criteria" for substantial equivalence.

Details on the "Study" (Non-Clinical Testing & Predicate Comparison)

This submission relies on non-clinical data and comparison to a predicate, not a clinical study in the sense of a trial with human subjects for performance evaluation.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (for Non-Clinical Testing): Not explicitly stated as a "sample size" in terms of number of data points or cases. It refers to "Functional laboratory tests conducted under foreseeable operating conditions." These tests would typically be performed on a sample of the manufactured device(s) to verify compliance with standards and functional requirements.
Data Provenance: The company is I-MOTION GROUP GLOBAL IBERICA S.L., located in Alcorcon, Madrid, Spain. The non-clinical testing was conducted in a laboratory context, and the results were submitted to the FDA (U.S. Food & Drug Administration). The exact location where these lab tests were performed is not specified, but it's presumed to be within a controlled, recognized testing facility. The nature of this submission (510(k)) means it's inherently retrospective in terms of comparing to an already cleared predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable in the typical sense of AI/diagnostic device ground truth. For a powered muscle stimulator 510(k) submission, "ground truth" is established through engineering and safety standards (e.g., IEC 60601 series, ISO 14971, FCC regulations) and verified through robust non-clinical testing conducted by qualified test engineers and laboratories. There isn't a "ground truth" established by human experts reviewing stimulation data or clinical outcomes in this type of submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert labeling tasks for AI models to resolve discrepancies in human interpretations. Non-clinical engineering tests rely on objective measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed/Not applicable. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The I-Motion device is a muscle stimulator, not an AI-driven diagnostic tool that would typically involve human readers or AI assistance in interpretation. The submission's focus is on direct comparison to a predicate device's established safety and effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable in the context of AI performance. The device itself is a "standalone" system in terms of its direct function as a muscle stimulator. Its performance is assessed through its physical characteristics and electrical outputs compared to established standards and the predicate device, not in terms of an algorithm's diagnostic or predictive accuracy. The "software/firmware/microprocessor control" component is acknowledged, and its impact is deemed not to affect safety/effectiveness based on non-clinical tests.

7. Type of Ground Truth Used

Engineering/Safety Standards and Predicate Device Characteristics: The "ground truth" for this submission is implicitly defined by:
- Compliance with recognized international and national standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10) and risk management (ISO 14971).
- The established safety and effectiveness profile of the legally marketed predicate device (WIEMSpro, K181955).
- Functional requirements and performance specifications derived from the device's intended use as a powered muscle stimulator.

8. Sample Size for the Training Set

Not applicable. This device is hardware for muscle stimulation. It is not an AI model that requires a "training set" of data for machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI training set, this question is not relevant to the described device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

May 26, 2022

I-Motion Group Global Iberica S.L. Jose Soto Belloso Managing Director Calle Loeches 66.8 CP Alcorcon, Madrid 28925 Spain

Re: K212413

Trade/Device Name: I-Motion, I-Motion Fit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 25, 2022 Received: April 26, 2022

Dear Jose Soto Belloso:

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,

for Heather Dean, PhD 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

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Indications for Use

510(k) Number (if known) K212413

Device Name I-Motion I-Motion Fit

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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1. INFORMATION

DATE OF SUBMISSION:	2021-April-01
SUBMITTER NAME:	I-MOTION GROUP GLOBAL IBERICA S.L.
SUBMITTER ADDRESS:	Calle Loeches 66.828925-Alcorcón, MadridSPAIN
CONTACT:	Jose Luis Soto Belloso
TELEPHONE:	+34 914 93 88 45
e-mail:	jl.soto@i-motion.es
DEVICE TRADE NAME:	I-Motion, I-Motion Fit
COMMON NAME:	Powered muscle stimulator.
CLASSIFICATION NAME:	Stimulator, Muscle, Powered, For Muscle Conditioning(21 CFR 890.5850)
PREDICATE DEVICE(S):	WIEMSpro (K181955)

2. DEVICE DESCRIPTION

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3. SUMMARY OF COMPARISON WITH PREDICATE DEVICE

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

WiEMSpro (K181955)
Comparison of the proposed devices with the predicate devices is summarized in the following table:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic/ Feature	PROPOSED DEVICEI-Motion	PREDICATE 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	N/A
	INTENDED USE
Intended use	Must be used for only healthymuscles and client. It is not intendedto be used in conjunction withtherapy or treatment of medicalconditions of any kind.	Must be used for only healthy musclesand client. It is not intended to be usedin conjunction with therapy or treatmentof medical diseases or medicalconditions of any kind..	Same
Indicationsfor use	I-MOTION is intended to stimulatehealthy muscles in order toimprove or facilitate muscleperformance, is not intended to beused in conjunction with therapy ortreatment of medical diseases ormedical conditions of any kind.None of I-MOTION trainingprograms is designed for injured orailing muscles and its use on suchmuscles is contraindicated.Each of the I-MOTION trainingprograms depending on theparameters of the electricalimpulses (pulse frequency,duration of contraction, duration ofrest, total session duration),different types of muscle work canbe imposed on the stimulatedmuscles.I-MOTION is a machine withelectronic muscle stimulationbased on EMS technology.Regarding its use, I-MOTION isspecifically designed as anaddition to other sports and fortraining muscles. It must be used	WIEMSPRO is intended to stimulatehealthy muscles in order to improve orfacilitate muscle performance. TheWIEMSPRO is not intended to be usedin conjunction with therapy or treatmentof medical diseases or medicalconditions of any kind. None ofWIEMSPRO training programs isdesigned for injured or ailing musclesand its use on such muscles iscontraindicated.WIEMSPRO is a machine withelectronic muscle stimulation based onEMS technology.Regarding its use, the device isspecifically designed as an addition toother sports and for training muscles. Itmust be used for only healthy musclesand clients, not for rehabilitationpurposes.WIEMSPRO electrical impulses allowthe triggering of action potentials onmotoneurones of motor nerves(excitations).These excitations of motoneurones aretransmitted to the muscle fibers via themotor endplate where they generate	Similar.Difference is theSoftware applicationwhich controls thedevice, not affecting thesafety, efficiency, orfunctionality of thedevice.
I-MOTION GROUPGLOBAL IBERICA			510(k) Premarket Notification	Image: i-motion logo
	510(k) SUMMARY
	rehabilitation purposes.		correspond to muscle work.Depending on the parameters of theelectrical impulses (pulse frequency,duration of contraction, duration of rest,total session duration), different typesof muscle work can be imposed on thestimulated muscles.
Prescription/Rx	Prescription only		Prescription only	Same
Useenvironment	Use in athletic training facilities. Notfor use outdoors		Use in athletic trainingfacilities. Not for useoutdoors	Same
Anatomicalsites	Electrodes can be applied tomultiple anatomical sites.		Electrodes can be appliedto multiple anatomicalsites.	Same
	TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE
PoweredMuscleStimulator	YES	YES		Same
PowerSource		Battery:2 x 3.7 V= 7,4V- 3,4AH (Lithium)	Battery:3.7V-2,4AH (LiPo)	SimilarMinimal differences in thetechnicalcharacteristic/performance,not affecting the safety,efficiency, or functionalityof the device
I-MOTION GROUPGLOBAL IBERICA	510(k) Premarket Notification		Image: imotion logo
510(k) SUMMARY
Method of linecurrentisolation	N/A (battery operated device)	N/A (battery operated device)	Same
Patient leakagecurrent-Normalcondition-Single faultcondition	N/A (battery operated device)N/A (battery operated device)	N/A (battery operated device)N/A (battery operated device)	Same
Battery operated	YES, lithium polymer cellrechargeable	YES, lithium polymer cellrechargeable	Same
Number ofOutput modes	One output mode, but with varyingstimulation frequency and dutycycle ranges	One output mode, but withvarying stimulationfrequency and duty cycleranges	Same
Number ofOutput channels- Synchronous orAlternating?-Method of ChannelIsolation	1 CHANNELAlternating	1 CHANNELAlternating	Same
Independentchannels withpossibility toregulate thecurrentindividually	10 CHANNELS	10 CHANNELS	Same
Current /Voltage	90mA/45V	125mA/62.5V	SimilarMinimal differencesin the technicalcharacteristic/performance, not affectingthe safety, efficiency, orfunctionality of thedevice.
Regulated currentand/or voltage	Yes, regulated current	Yes, regulated current	Same
Software/Firmware/MicroprocessorControl?	Yes	Yes	SimilarMinimal differencesin the technicalcharacteristic/performance, not affectingthe safety, efficiency, orfunctionality of the device.
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 directlypause the program	Yes, push on On/Offbutton directly pause theprogram	Same
Indicatordisplay	Yes	Yes	Same
-On/Off status?	Yes	Yes	Same
-Low Battery?	Yes	Yes	Same
Voltage/Current level?	Yes	Yes	Same
Pulse duration(width)	150-450 µsec	100-400 µsec	Same
Frequency	1-100 Hz	1-100 Hz	Same
Time range(minutes)	Maximum program: unlimited	Maximum program: unlimited	Same
PlasticHousingMaterials	PLASTIC	PLASTIC	Same
Device Weight	300 g	300 g	Same
Dimensions(in.) [W x H xD]	[5,3 x 2,7 x 1,7] in	[6,66 x 3,27 x 1,18] in	Similar
Reusable Pads	Yes	Yes	Same
Compliancewith voluntarystandards /LAB testsperformed	IEC 60601-1:2005 (ed. 3.0) +corrigendum 2006+ corrigendum2007 + interpretation sheet 2008 +interpretation sheet 2009 +A1:2012IEC 60601-1-6:2010 (ed.3.0) +A1:2013IEC 60601-1-2-10:2010 (ed.2.0) +A1:2016IEC 62304:2006ISO 14971:2019	IEC 60601-1:2005IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-2-10:2012FCC 47 CFR Part 15IEC 62304:2006ISO 14971:2007	SimilarAll thecorrespondingstandard normsare complied with,the minimumdifference is dueto the updating ofthe new versionsof the norms.
Waveform(e.g., pulsedmonophasic,biphasic)(program perprogram)	Symmetrical biphasic (all programs)	Symmetrical biphasic (allprograms)	Same
Maximumoutputvoltage	110V	170V	SimilarMinimal differences in thetechnicalcharacteristic/performance, not affecting the safety,efficiency, or functionalityof the device.
Maximumoutputcurrent	90mA	125mA	SimilarMinimal differences in thetechnicalcharacteristic/performance,not affecting the safety,efficiency, or functionality ofthe device.
Maximumpowerdensity	9 mW/cm²@500ohm	9,61mW/cm²@500ohm	SimilarMinimal differences in thetechnicalcharacteristic/performance, not affecting the safety,efficiency, or functionalityof the device.
I-MOTION GROUPGLOBAL IBERICA	510(k) Premarket Notification
	510(k) SUMMARY
Maximumcurrentdensity		1.87mA/cm²Smallest electrode size: 48cm²	1.92mA/cm² Smallest electrodesize:65cm²	SimilarMinimal differences in thetechnicalcharacteristic/performance, not affecting the safety,efficiency, or functionalityof the device.
Forinterferentialmodes only:BeatFrequency(Hz)		N/A	N/A	N/A
Formultiphasicwaveformsonly:Symmetricalphases?		N/A	N/A	N/A
PhaseDuration(include units)(state range, ifapplicable)(both phases,ifasymmetrical)		N/A	N/A	N/A
Net Charge(µC per pulse)(If zero, statemethod ofachieving zeronet charge.)		N/A	N/A	N/A
MaximumPhase Charge,(µC)		N/A	N/A	N/A
Burst Mode(i.e., pulsetrains)		N/A	N/A	N/A
ON Time(seconds)		N/A	N/A	N/A
OFF Time(seconds)		N/A	N/A	N/A
Electrodes		Silicone conductive electrodes;reusable They never come intodirect contact with the skin, as	Conductive fabric,reusable electrodes (not indirect contact with skin)	Same
510(k) SUMMARY
	cotton covers and garments areused on the user's body.9 pairs of electrodes, stimulatingonly one muscle group at a timeSizes: 96 cm2 and 48 cm2	9 electrode pairs and eachpair of electrodes movesonly one group of musclesimultaneously.Sizes:65 cm283 cm2
Connectionelectrodeswithstimulator/cables	PIN 2 mm	Lead wiresStainless steel snapfastener	SimilarMinimal differencesin the technicalcharacteristic/performance, not affectingthe safety,efficiency, orfunctionality of thedevice.
Conductivitymédium	The subject needs to puton an 100% hygroscopiccotton underwear(surgery textile,biocompatibility certified)and these underwearneeds to besoaked/irrigated withnormal tap water. So theelectro conductive mediais simply tap wateredcotton which is in contactwith the electrodes. Thesurface of the electrodewill not get dry. In this case thepulsetransmission efficiencywill not decrease. Thesmall conductive pads arewashable and disinfectable.	The subject needs to puton an 100% hygroscopiccotton underwear(surgery textile,biocompatibility certified)and these underwearneeds to besoaked/irrigated withnormal tap water. So theelectro conductive mediais simply tap wateredcotton which is in contactwith the electrodes. Thesurface of the electrodewill not get dry. In thiscase the pulsetransmission efficiencywill not decrease. Thesmall conductive pads arewashable anddisinfectable.	Same

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i-motion

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I-MOTION GROUP GLOBAL IBERICA

510(k) Premarket Notification

i-motion

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I-MOTION GROUPGLOBAL IBERICA	510(k) Premarket Notification	Image: i-motion logo
510(k) SUMMARY

None of the differences presented above impact the equivalence of the subject device when compared to the predicate devices.

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4. INDICATIONS FOR USE

As established in the Indications for Use Statement:

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

II-MOTION 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.

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.

None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

5. SUMMARY DISCUSSION OF NON-CLINICAL DATA

The proposed device has been subject to be testing to determine conformance to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.

Functional laboratory tests conducted under foreseeable operating conditions showed proper operation of the device according to its intended use, including specifically:

Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
Electromagnetic compatibility -
FCC Radio Frequency Testing The I-MOTION device was tested to FCC requirements and found to comply with the requirements of 47CFR Part15 n15.107and n15.109.

The new device is designed and manufactured in accordance with the following standards:

IEC 60601-1:2005 3rd edition .
IEC 60601-1-2:2007
IEC 60601-2-10:2012 ●

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I-MOTION GROUPGLOBAL IBERICA	510(k) Premarket Notification	Image: i-motion logo
510(k) SUMMARY

IEC 60601-1-6 Edition 3.1 2013-10

6. SUMMARY DISCUSSION OF CLINICAL DATA

Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence.

7. CONCLUSIONS

We believe the intended use, the indications for use and principle of operation of I-MOTION are the same as the intended use, indications for use and performance of the predicate devices. 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 minimum differences in the technological characteristic/performance at a of the proposed device and those of the predicate devices, nevertheless, all of them comply with IEC60601-1-2, IEC60601-2-10. Thus, the SE is not affected.

Based on the information provided in this pre-market notification, concludes that I-MOTION is substantially equivalent to the predicate device regarding 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).