miha bodytec II 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 healthy muscles and clients, not be used for rehabilitation purposes.

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

The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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.

The various types of muscle work that the miha bodytec II can impose on the stimulated muscles are able to improve or facilitate muscle performance. The miha bodytec II may therefore be considered a technique of muscle training.

Device Description

miha bodytec II is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. These excitations of motor nerves are transmitted to the muscle fibers where they stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles.

miha Bodytec II consists of a control unit mounted on a stand for the selection of programs, setting the parameters and starting/stopping the device, the i-body® electrode vest for applying electrodes to the upper body, i-body® straps for applying electrodes to the arm and legs and the i-body® belt for applying electrodes to the buttocks. The control unit and the i-body® accessories are connected via cables and must be worn on top of optionally available undergarment.

miha bodytec II must be used in a professional sport setting. The device must be operated by a trainer who has received a full training from the manufacturer. Before the trainer selects the accessories incl. electrodes in the correct size, applies the athlete i.e. by wearing the electrode vest and connects the straps und belt via cable to the vest and to the control unit. The trainer can choose between several training programs on the control unit for impulse familiarization, invigoration basic/advanced, muscular endurance and body relax. The intensity can be adjusted by the trainer at the UI of the control unit separately for each channel. Complete body training which addresses all muscle groups is possible with up to 10 pairs of electrodes. Each athlete receives an RFID transponder card for storing training results and individually adjusted programs. Once the training is started, the control unit generates and transmits the electrical signals to the electrodes via cable. miha bodytec II uses bipolar pulses and supplies all channels equally during all programs.

AI/ML Overview

The provided document is a 510(k) Summary for the miha bodytec II device, which is a powered muscle stimulator. It details various aspects of the device and its comparison to a predicate device (E-Fit EF-1280) to demonstrate substantial equivalence for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Important Note: This document is a 510(k) Summary for a Powered Muscle Stimulator, not an AI/ML-enabled diagnostic device for medical imaging. Therefore, many of the typical "acceptance criteria" and "study" elements related to AI algorithm performance (like sensitivity, specificity, MRMC studies, expert consensus for ground truth on imaging data, sample sizes for training/test sets, etc.) as you might expect for an AI diagnostic tool, are not applicable here. The acceptance criteria for this device are focused on electrical safety, electromagnetic compatibility, software validation, usability, biocompatibility, and bench testing to demonstrate functional characteristics and shelf life.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance (Compliance/Results)
Electrical Safety	Compliance with AAMI ANSI ES 60601-1_2005/(R)2012 And A1:2012	In compliance.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014	In compliance.
Software/Firmware Validation	Compliance with IEC 62304:2015 and FDA's "General Principles of Software Validation"	Verified and validated; firmware met software system requirements.
System Validation (Functional)	Oscilloscope tracings of output waveforms under various loads (500 Ω, 2 kΩ, 10 kΩ) with maximum supported voltage and pulse widths.	Tracings obtained (results not explicitly detailed but implied compliance with expected output).
System Validation (Functional, Other)	Electrical tests of interfaces, thermographic inspections, climate chamber tests, shock and vibration tests.	Conducted (results not explicitly detailed but implied compliance).
Usability Validation	Compliance with IEC 62366-1:2015 and FDA's guidance on usability. Confirmation that device meets intended use safely and effectively by specified users in specified environment, considering human factors.	Overall system validated; UI tested for usability according to FDA's guidance.
Biocompatibility	Skin contacting material tested to ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2009 (irritation/sensitization).	Tested to these standards (results implied acceptable).
Shelf Life	Accelerated aging simulation (60°C for 4 weeks) with typical training current applied to electrodes; tested for 1-year shelf life and 1-year storage.	All tests successfully passed.
Dispersion Testing (Electrodes)	Uniform current distributions bench testing using 4 batches of electrodes (8 chest, 8 lateral back, 1 upper back, 1 abdomen electrode from each batch). Measurements taken prior to and after cleansing, and after accelerated aging.	All tests successfully passed.
Output Specifications (Comparison to Predicate)	Max Output Voltage: miha bodytec II: <= 74Vp @ 500Ω, <= 152Vp @ 2kΩ, <= 152Vp @ 10kΩ. E-Fit EF-1280: 36V @500Ω. Max Output Current: miha bodytec II: < 148mAp @ 500Ω, < 76mAp @ 2kΩ, < 15 mAp @ 10kΩ. E-Fit EF-1280: 72mA @500Ω. Max Power Density: miha bodytec II: 0.82 mW/cm² @ 500Ω. E-Fit EF-1280: 6.3 mW/cm² @ 500Ω.	Differences were noted but considered not to raise new questions regarding safety and effectiveness, as both devices comply with IEC 60601-2-10 limits.
Compliance with General Controls	Annual registration, listing, labeling, GMP, prohibitions against misbranding and adulteration.	The FDA letter reminds the applicant of these ongoing requirements.

Study Details (as applicable to this type of device)

As this is a 510(k) for a powered muscle stimulator, the "study" is primarily a series of engineering, biological, and bench tests demonstrating compliance with recognized standards and substantial equivalence to a predicate device, rather than a clinical study involving human subjects or an AI model's performance on a dataset of medical images.

2. Sample size used for the test set and the data provenance:

Electrical Safety & EMC, Software, Usability, System Validation: These tests are typically performed on a representative number of manufactured units of the device (e.g., a few units, or internal test benches). The document doesn't specify a "sample size" in the context of a dataset of patient data, as it's not applicable. Provenance isn't relevant as it's testing the device itself.
Biocompatibility: Testing was performed on the "skin contacting material." No specific "sample size" of patients or data is provided as it's material testing.
Shelf Life & Dispersion Testing:
- Dispersion: "4 batches of electrodes were tested. From each batch 8 chest-electrodes (yellow), 8 lateral back-electrodes (blue), 1 upper back-electrode (green) and 1 abdomen-electrode (red) were selected." This translates to a total of (8+8+1+1) * 4 = 72 electrodes for dispersion testing.
- Shelf Life: "Altogether 72 electrodes were tested."
- Data Provenance: This is bench testing of the physical electrodes/device components. It's not human patient data, so concepts like country of origin or retrospective/prospective don't apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/ML diagnostic tool requiring human expert annotation to establish ground truth on medical images. The "ground truth" for this device's performance is objective measurements (electrical parameters, material properties, software function validated against requirements, etc.) and compliance with engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This relates to human expert consensus or resolving discrepancies in diagnostic interpretations, which is not relevant for the type of testing described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a powered muscle stimulator, not a diagnostic AI device to be used by human readers for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. While the device does have firmware/software, its purpose is to control the muscle stimulation, not to perform an independent diagnostic analysis. The performance is assessed based on its ability to generate the specified electrical impulses safely and effectively when operated by a trained user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the usual sense for AI diagnostics. For this device, "ground truth" is established by:
- Reference Standards: Adherence to recognized national and international standards (IEC 60601 series, ISO 10993 series, etc.) for electrical safety, EMC, software, and biocompatibility.
- Engineering Specifications: The device's output (voltage, current, pulse width, frequency) is measured against its own design specifications and the limits set by relevant standards.
- Functional Benchmarks: Performance testing to confirm the device operates as intended (e.g., uniform current distribution in electrodes, successful completion of aging tests).

8. The sample size for the training set:

Not applicable. This device does not use machine learning in a way that requires a "training set" of data in the typical sense of AI/ML development for diagnostic tasks. Its firmware is validated as traditional software, not trained on data.

9. How the ground truth for the training set was established:

Not applicable. As there is no "training set" for AI/ML, there's no ground truth established in that context.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2019

miha bodytec GmbH % Rhonda Alexander Sr. Consultant, Leadership & Regulatory Development IUVO Consulting, LLC P.O. Box 56483 Virginia Beach, Virginia 23456

Re: K182519

Trade/Device Name: miha bodytec II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 3, 2019 Received: May 6, 2019

Dear Rhonda Alexander:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 Vivek Pinto Assistant Director, Acute Injury 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) K182519

Device Name miha bodytec II

Indications for Use (Describe)

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

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

for

miha bodytec II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

1 Sponsor

Sponsor:	miha bodytec GmbHSiemensstr. 186368 GersthofenGermany
Contact Person:	Dr. Rhonda AlexanderIUVO Consulting, LLC(757) 582-4337ralexander@iuvoconsulting.com

Date Prepared: May 2, 2019

2 Device Name and Classification

Proprietary Name: miha bodytec II

Common/Usual Name: Powered muscle stimulator

Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning (21 CFR 890.5850, Product Code NGX)

Predicate Device 3

E-Fit EF-1280, K133225 Predicate Device:

Intended Use 4

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5 Device Description and Function

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During pulse application, the trainer instructs the athlete on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button.

Predicate Device Comparison б

6.1 General

Characteristic	New Device	Predicate Device	Similar / Different
510(k) Number	K182519	K133225	-
Device Name,Model	miha bodytec II	E-Fit EF-1280	-
Manufacturer	miha bodytec GmbH	Fit-Pro KFT Ltd.	-
Indications forUse	miha bodytec II is a machinewith electronic musclestimulation based on EMStechnology. Regarding itsuse, the device is specificallydesigned as an addition toother sports and for trainingmuscles. It must be used forhealthy muscles and clients,not be used forrehabilitation purposes.	E-fit EF-1280 is amachine withelectronic musclestimulation based onEMS technology.Regarding its use, thedevice is specificallydesigned as anaddition to othersports and for trainingmuscles. It must beused for only healthymuscles and clients,not for rehabilitationpurposes.	There are no differencesbetween the subjectdevice and thepredicate(s) with respectto indications andintended use.
	miha bodytec II is intendedto stimulate healthy musclesin order to improve orfacilitate muscleperformance. miha bodytecII is not intended to be usedin conjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind. Noneof the miha bodytec IItraining programs aredesigned for injured or ailingmuscles and its use on suchmuscles is contraindicated.	The E-Fit EF-1280intended to stimulatehealthy muscles inorder to improve orfacilitate muscleperformance. The E-Fit EF-1280 is notintended to be usedin conjunction withtherapy or treatmentof medical diseases ormedical conditions ofany kind. None of theE-Fit EF-1280 trainingprograms is designedfor injured or ailingmuscles and its use	-
The miha bodytec II		on such muscles is
electrical impulses allow the		contraindicated.
triggering of action
potentials on motoneurons
of motor nerves	The E-Fit EF-1280
(excitations). These	electrical impulses
excitations of motoneurons	allow the triggering of
are transmitted to the	action potentials on
muscle fibers via the motor	motoneurones of
endplate where they	motor nerves
generate mechanical muscle	(excitations). These
fiber responses that	excitations of
correspond to muscle work.	motoneurones are
Depending on the	transmitted to the
parameters of the electrical	muscle fibers via the
impulses (pulse frequency,	motor endplate
duration of contraction,	where they generate
duration of rest, total	mechanical muscle
session duration), different	fiber responses that
types of muscle work can be	correspond to muscle
imposed on the stimulated	work. Depending on
muscles.	the parameters of the
	electrical impulses
	(pulse frequency,
	duration of
	contraction, duration
	of rest, total session
The various types of muscle	duration), different
work that the miha bodytec	types of muscle work
II can impose on the	can be imposed on
stimulated muscles are able	the stimulated
to improve or facilitate	muscles.
muscle performance. The
miha bodytec II may
therefore be considered a	The various types of
technique of muscle	muscle work that the
training.	E-Fit EF-1280 can
	impose on the
	stimulated muscles
	are able to improve or
	facilitate muscle
	performance. The E-
	Fit EF-1280 may
	therefore be
	considered atechnique of muscle
	training.

Connection ofthe device toelectrodes	One stimulation module /control unit which ischannel-wise connected tothe i-body® electrodes overa cable to the i-body® vest.The electrodes of the i-body® straps and belt areconnected via cables to thevest.	One stimulationmodule / main unitwhich is channel-wiseconnected to the EF-jacket and EF-shorts.	Similar electrodeconnection from acontrol unit to theelectrodes
PowerSource(s)	Control unit: 15 V - 19 V;External power supply (100- 240 V ~ 50 - 60 Hz)	12V (3,4Ah) lead Acidbattery	Different. The externalpower supply of subjectdevice was testedaccording to AAMI/ANSIES 60601-1:2005/(R)2012and A1:2012. No newconcerns regarding safetyand effectiveness wereraised during verificationand validation.
- Method ofLine CurrentIsolation	Power Supply in accordancewith IEC 60601-1	N/A (battery operateddevice)	Different. See commenton power source.
- PatientLeakageCurrent	< 100 μΑ	N/A (battery operateddevice)	Different. See commenton power source.
- Normalcondition	< 100 μΑ	N/A (battery operateddevice)	Different. See commenton power source.
- Single faultcondition	< 100 μΑ	N/A (battery operateddevice)	Different. See commenton power source.
Number ofOutput Modes	One (symmetric biphasic)with 6 training programs	One (symmetricbiphasic)	Similar. Both devicesprovide one outputsymmetric biphasicoutput mode.
Number ofOutputChannels	10, channel selectivestimulation.Maximum one channel isactive at any time.	10+2. The outputchannel can shift intime to the 12outputs but electricalcurrent can beregulated individuallyon every output	Similar, both devices usemultiplexing andalternating activation ofthe output channels.
- Synchronousor Alternating	Alternating	Alternating	Similar, see commentabove.
- Method ofChannelIsolation	Multiplexed by control unit	Multiplexed bycontrol unit	Similar, see commentabove.
RegulatedCurrent orRegulatedVoltage	Regulated voltage (allchannels)	Regulated current (allchannels)	Different regulationmechanism. However,both are safe andeffective and comply withIEC 60601-2-10.
Software/Firmware/MicroprocessorControl	Yes	Yes	Similar. Both devices arefirmware-driven.
AutomaticOverload Trip	Yes, no load and short circuitconditions are handled	Yes	Similar. Both devices no-load and overloadcondition handling.
Automatic No-Load Trip	Yes, no load and short circuitconditions are handled	Yes	Similar. Both devices no-load and overloadcondition handling.
Automatic ShutOff	On/Off-Switch, stimulationstops after defined duration,automatic stop ofstimulation in case of failure/ malfunction detected	On/Off-Switch,Watchdogmonitoring, hardwareerror monitoring,output currentmonitoring(emergency stopoption)	Similar. Both devicesprovide a hardwareon/off-switch as well aserror monitoringimplemented in thefirmware.
PatientOverrideControl	Yes, while a program isactive the patient issupervised by a trainer andable to manipulate intensity(amplitude) and push thestop button	Yes, while a programis active the patient issupervised by atrainer and able tomanipulate intensity(amplitude) and pushthe pause button	Similar, both devicesrequire the operation bya qualified trainer.
IndicatorDisplay:	Yes	Yes	Similar, both devicesprovide a display.

- On/Off Status	Yes	Yes	Similar, both devicesshow the on/off status.
- Low Battery	N/A, no battery	Yes	Different. Not applicableto miha bodytec II sinceno battery is used.
- Voltage/Current Level	Yes, displayed in form ofpercentage / value range	Yes, displayed in formof percentage / valuerange	Similar, both devicesdisplay the voltage /current level.
Timer Range /ProgramDuration(minutes)	Training should not exceed20 minutes; Screen showsremaining time in minutesand displays image showingtime remaining	Maximum = 30minutes	Similar, bothmanufacturersrecommend a similarmaximum trainingduration.
Number ofPrograms	11	5+5	Similar number ofprograms / training plans.
User Interface	Physical buttons and rotaryknobs with pictographs ofthe trained muscles for aquick und usability-orientedsetting of the intensityvalues and multi-functionalbutton for setting, programselection and START/STOPfor immediate stimulationstop, power-off button, RFIDtransponder card placementarea.10.1 inch non-touch LC colordisplay for program /training plan selection viamenu, settings, devicestatus, training mode display(animated avatar, timer,selected program)	The rotary encoderallows for a quick set-up and because of thepush buttoncapability, theprogram can bestopped immediatelyfor every channel.There are largeSTART/STOP andPOWER off buttons tobegin the programand for completepower shutdown.Because of thepictographs and fixedelectrodes in theclothing, it is veryappropriate musclegroups.Simple one-levelmenu system.LC 2x40 character LCDdisplay with LEDbacklight.	Similar. However, mihabodytec II provides alarger display forchanging settings,choosing programs /training plans, andproviding relevantinformation duringtraining. The UI of mihabodytec was tested forusability according toFDA's guidance.
Portability /Mobile Use	Portable with difficulty, nomobile device, its intended	Portable withdifficulty, no mobile	Similar, both devices areportable with difficulty.

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Operator	use requires the qualified and trained operator.The device must only be operated by a trainer, who received full training by miha bodytec.	device, its intended use requires the qualified and trained operator.By manufacturer recommendations, the only person who can operate the device must obtain certifications by the seller. This person must complete the certification prior to use on a patient.	Similar. Both devices require operation by a qualified trainer who received a manufacturer training.
Compliance with 21 CFR 898(Mandatory since May 9, 2000)	Yes	Yes	Similar
Size of electrodes	Electrodes with pre-defined size of $9.75 - 64.36 in^2$ , supplied with the device.Length x Width of electrode pads:3,42 - 30,94 in x 3,15 - 4,37 in	Electrodes with pre-defined (supplied with the device) size and correct position from $12.40 in^2$ to $58.13 in^2$ .Length x Width of electrode pads:3,94 – 9,84 in x 3,94 – 6,30 in	Similar size of electrodes.
	Vest size Size 1 and size V1 in in² Size 2, size 3 and size v2 in in² 2 electrodes for abdomen 22.85 27.56 2 electrodes for chest 10.31 12.81 2 electrodes for upper 16.25 20.98

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2electrodesfor sidesof back	9.75	11.85
2electrodesfor lowerback	14.4	19.47
Strap size	Electrodesize in²
Size 1(pair)	Each 34.15
Size 2(pair)	Each 48.77
Size 3(pair)	Each 64.36
Strap size	Electrodesize in²
Size 1(pair)	Each 14.7
Size 2(pair)	Each 18.34
Plugs	Main cable with D-Sub 25pin connector to the controlunit and proprietarymagnetic connector to the i-body vest. Cables betweenvest and strap / belt withproprietary connectors.	Cables connect to theelectrodes with snapfastener and connectto the machine withplastic 12pinwaterproof ip68connector.	Different plug design.However both deviceshave been successfullytested according to therelevant recognizedsafety standards (IEC60601).
Lead wires -cables	1. Main cable with D-Sub 25pin connector to the controlunit and proprietarymagnetic connector to the i-body vest. Length: 3000 mm,Polyurethane jacket.	SIFF 1-1.5mm² (1x375unique filaments)ultra flexible –Compliant withprotected lead wireand patient cablesafety requirements	Similar. Both deviceshave been successfullytested according to therelevant recognizedsafety standards (IEC60601).
	2.1-pole-cables betweenvest and strap / belt: 15,75in, 19,29 in, 30,71 in, PVCjacket.
	3. Cables within vest:firmly mounted into the
Placement ofthe electrodes	Compliant with protectedlead wire and patient cablesafety requirementsAppropriately pre-placedin specific areas accordingto muscle anatomy.Electrodes are firmlymounted into the vest, beltor straps. The electrodesitself cannot be separatedfrom the textile and cannotbe exchanged.	Appropriatelypreplaced in specificareas according tomuscle anatomy.Electrodes are onlyfixed by velcro andcan be exchanged.	Similar areas of electrodePlacement.Different possibility toexchange the electrodes.However, with the mihabodytec II there is no riskof incorrect electrodesbeing used by mistake.
Material ofelectrodes	The conductive electrodeitself (under the textile) ismade out of a 100%BEKINOX Stainless Steelmultifilament yarn.No direct skin contactpossible.	No direct skincontact. Furtherinformation notpublicly available.	N/A
Maximumduration foruse pertreatment	Max. 20 minutes pertreatment.	Max. programduration 30 minutes.	Similar
Conductivity ofthe electrodes	The athlete needs to put onthe genuine andbiocompatible miha bodytecundergarments (pants andshirt) under the i-bodyaccessories (vest, strap andbelt).The absorbent electrodescover on the i-body vest,strap and belt need to bemoistened using a pumpspray bottle with tap water.The electrode vest, strapsand belt are washable.	The subject needs toput on an 100%hygroscopic cottonunderwear (surgerytextile,biocompatibilitycertified) and theseunderwear needs tobe soaked / irrigatedwith normal tapwater. So the electroconductive media issimply tap wateredcotton which is incontact with theelectrodes. Thesurface of theelectrode will not getdry. In this case thepulse transmissionefficiency will notdecrease. The smallconductive pads are	Different. However, bothapproaches are effective,the difference of mihabodytec II is that theundergarments do notneed to be completelysoaked with water.
		washable anddisinfectable.
Accessories	i-body vesti-body strapi-body beltUndergarmentsTransponder card	EF-JacketEF-ShortsEF arm and shouldstrapsUndergarments	Similar types ofaccessories.
Weight	Complete: 45.2 lbControl unit: 10.3 lbi-body® with cable set: 3.3 lbi-body® belt: 0.9 lbi-body® strap: 0.55 lb	Complete: 53.57 lb	Similar in weight.
Dimensions(ft.) [W x H x D]	Control unit: $1.39 × 0.89 × 0.23$ (W × D × H in ft)Complete: $1.77 × 1.69 × 3.89$ (W x D x H in ft)	Control unit: $1.43 x 0.26 x 0.85$ (W × D × Hin ft)	Similar in dimensions.
HousingMaterials andConstruction	Control unit:Aluminum	Enclosure:Stainless steel	Different housingmaterial. However, bothdevices have beensuccessfully testedaccording to the relevantrecognized safetystandards (IEC 60601).
Standards	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 AndA1:2012IEC 60601-1-2:2014IEC 60601-1-11:2010IEC 60601-2-10:2012IEC 62304:2015IEC 62366-1:2015ISO 10993-1:2009	ISO 14971:2012EN ISO 13485:2003/AC2009IEC 60601-1:2005 3rdeditionIEC 60601-1-2:2007IEC 60601-1-11:2010IEC 60601-2-10:2012	Similar, several additionalstandards applied bymiha bodytec

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Table 1: Basic Device Characteristics – Comparison with Predicate Device

6.2 Output Specifications

Characteristic	New Device	Predicate Device	Similar / Different
Waveform	Symmetric biphasic	Symmetric biphasic	Similar output.
Shape	Rectangular	Rectangular	Similar shape.
MaximumOutput Voltage	<= 74Vp @ 500Ω (54 - 74 Vp)<= 152Vp @ 2kΩ(110 ... 152 Vp)<= 152Vp @ 10kΩ(130 ... 152 Vp)	36V @500Ω	Different maximumoutput values. However,this does not raise newquestions regardingsafety and effectivenesssince both devicescomply and are withinthe limits of IEC 60601-2-10.
MaximumOutput Current	< 148mAp @ 500Ω(108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ(13-15mAp)	72mA @500Ω	Different maximumoutput current.However, this does notraise new questionsregarding safety andeffectiveness since bothdevices comply and arewithin the limits of IEC60601-2-10.
Pulse Width	50 - 400 μs	100 - 500 μs	Similar pulse width.
Frequency (Hz)	2 - 150 Hz	5 - 120 Hz	Similar frequency.
Symmetricalphases	Yes	Yes	Similar
Phase Duration	25 ... 200 µs	50 ... 250 µs	Similar phase duration.
MaximumPhase Charge	<32 µC @ 500Ω	36 µC @ 500Ω	Similar maximum phasecharge
MaximumCurrent Density	0.64 mA/cm² @500Ω	0.85 mA/cm² @ 500Ω	Similar maximum currentdensity
MaximumPower Density	0.82 mW/cm² @500Ω	6.3 mW/cm² @ 500Ω	Different maximumpower density. However,both devices fulfill therequirements of IEC60601-2-10.
Burst Mode	Contraction time: 1 - 10 sRelaxation time: 0.0 - 10 s	Contraction time: 0.1 - 30 sRelaxation time: notspecified	Similar burst mode
Safety circuits	Short-circuitmonitoring,watchdogmonitoring, no loadtrip, onload trip,button forimmediate shut off,redundant hardwareerror monitoring(emergency STOPoption)Firmware self-tests.	Short-circuitmonitoring, watchdogmonitoring, no loadtrip, onload trip,battery monitoring,battery voltagemonitoring, outputcurrent monitoring(emergency STOPoption), option for self-test, hardware errormonitoring.	Similar safety featuresprovided.

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Table 2: Output Specifications – Comparison with Predicate Device

6.3 Summary of technological characteristics:

Miha bodytec II and the predicate device have the same indications for use and similar technological characteristics and features. Both use wired connections between the control unit to the electrodes, specifically designed biocompatible undergarment, electrode connector accessories which are placed on the undergarment and not directly on the skin and slightly different output specifications, cable specifications, however, both within the limits given by IEC 60601-2-10. miha bodytec II is powered by line voltage, whereas the E-Fit 1280 is battery-driven. The power supply is located outside the control unit and was tested according to IEC 60601-1. No additional concerns regarding safety and effectiveness were raised.

None of these differences raise any new issues regarding safety or effectiveness.

Performance Testing 7

Electrical Safety and Electromagnetic Compatibility testing: miha bodytec II was tested according to and is in compliance with recognized standards for electrical safety and electromagnetic compatibility.

Software and System validation: The miha bodytec II comprises firmware which was verified and validated according to IEC 62304 and FDA's guidance: General Principles of Software Validation. Software validation demonstrated that the firmware met the software system requirements. The full system validation testing also included testing in accordance with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ. Additional System-level tests were conducted, including electrical tests of the interfaces, thermographic inspections, tests in climate chamber, shock and vibration tests.

Usability validation: The overall system was validated to confirm that the device meets its intended use, i.e. can be used safe and effectively by the specified users within the specified use environment, taking into account human factors and usability requirements.

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Biocompatibility testing: Skin contacting material was tested to ISO 10993-5:2009 and ISO 10993-10:2009.

Shelf life and dispersion testing:

Bench testing of the electrodes was performed to demonstrate uniform current distributions (dispersion testing). The test case was built up according to FDA's requirements.

4 batches of electrodes were tested. From each batch 8 chest-electrodes (yellow), 8 lateral backelectrodes (blue), 1 upper back-electrode (green) and 1 abdomen-electrode (red) were selected (see Annex III). The electrodes were cut out of the vest and moistened to be covered by the undergarments. 8 measure points from each chest-electrode (yellow), each lateral back-electrode (blue) and each upper back-electrode (green) as well as 5 measure points from each abdomenelectrode (red) were defined. As indicated by FDA the electrodes were measured prior to and after cleansing. After this measuring period the accelerated aging was applied and followed by another measuring period which was conducted exactly the same like the first one. All tests successfully passed.

To calculate the shelf life, we establish new testing according to ASTM F 1980-16. In a climate cabinet an accelerating aging condition for the electrodes was simulated at 60°C for 4 weeks. Through conducting a typical training current while being in the climate cabinet, a 1 year shelf life as well as a 1 year storage was tested. Altogether 72 electrodes were tested. All tests successfully passed.

Performance Standards 8

miha bodytec II complies with the applicable requirements of the following international and

national standards:

. IEC 60601-2-10:2012 - Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
IEC 60601-1-2:2014 - Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
AAMI ANSI ES 60601-1_2005/(R)2012 And A1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
. IEC 60601-1-11:2010 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62304:2015 - Medical Device Software - Software Life Cycle Processes

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. ISO 14971:2007 - Medical Devices - Application Of Risk Management To Medical Devices
. IEC 62366-1:2015 - Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
. ISO 10993-1:2009 - Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
ISO 10993-5:2009 - Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
. ISO 10993-10:2010 - Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

The following FDA Guidance Documents have been applied:

Guidance Document for Powered Muscle Stimulator 510(k)s, Document issued on: June 9, 1999
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005
General Principles of Software Validation issued on: January 11, 2002
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Document issued on: June 14, 2013
Cyber security for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, . Document issued on: January 14, 2005
. Off-the-Shelf Software Use in Medical Devices, Document issued on: September 9, 1999

Conclusion ு

Based on the comparison of the intended use, technological characteristics and performance testing, miha bodytec believes that the miha bodytec II system is substantially equivalent to the predicate device E-Fit EF-1280.

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).