miha bodytec II (MBT 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.

miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:

· Re-educating muscles
· Relaxation of muscle spasm
· Retarding or preventing disuse muscle atrophy

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

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 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.

AI/ML Overview

This document is a 510(k) summary for the "miha bodytec II" powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation study. Therefore, most of the requested information (regarding expert readers, MRMC studies, ground truth, training sets, etc.) is not applicable to this type of regulatory submission.

However, I can extract the information related to the device's technical acceptance criteria and the engineering and bench testing performed to prove it meets those criteria.

Here's a breakdown of what can be inferred and what is not applicable based on the provided text:

Key Takeaway: This document is a regulatory submission for device clearance based on substantial equivalence, not a clinical study demonstrating performance against specific disease detection acceptance criteria. The "acceptance criteria" here relate to engineering performance, safety standards, and functional specifications, not diagnostic accuracy metrics.

Acceptance Criteria and Reported Device Performance (Engineering/Safety)

The "acceptance criteria" in this context are primarily defined by compliance with recognized electrical safety, electromagnetic compatibility, and software validation standards, as well as functional equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion (Generally Implied by Standards Compliance & Comparison)	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance (as stated in document)
Electrical Safety	Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-10:2016 (limits for current, voltage, leakage, etc.)	Tested according to and in compliance with recognized standards. Specific values mentioned in comparison tables are within these limits.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014	Tested according to and in compliance with recognized standards.
Software Validation	Compliance with IEC 62304 and FDA's Guidance: General Principles of Software Validation; meeting software system requirements.	Firmware verified and validated. Software validation demonstrated firmware met software system requirements.
Usability	Meets intended use safely and effectively by specified users in specified environment (human factors and usability requirements).	Overall system validated. Usability tests successfully conducted following FDA's guidance.
Shelf Life of Electrodes	Demonstrated 1-year shelf life and 1-year storage.	Tested according to ASTM F1980-16 with accelerated aging (60°C for 4 weeks). 72 electrodes tested. All tests successfully passed.
Current Distribution (Dispersion Testing) of Electrodes	Uniform current distribution.	Bench testing performed according to FDA's requirements. 4 batches of electrodes tested (8 chest, 8 lateral back, 1 upper back, 1 abdomen). Measured prior to and after cleansing, and after accelerated aging. All tests successfully passed.
Output Waveforms	Symmetric biphasic, rectangular shape, specific voltage/current ranges (within IEC 60601-2-10 limits).	Oscilloscope tracings obtained under max supported voltage/pulse widths at 500 Ω, 2 kΩ, and 10 kΩ. Values provided in "Output Specifications" table, all stated to comply and be within limits of IEC 60601-2-10.
Operational Safety Features	Short-circuit monitoring, watchdog monitoring, no load trip, onload trip, immediate shut-off button, redundant hardware error monitoring, firmware self-tests.	All these features are listed as present in the "miha bodytec II" and the primary predicate.

Study Details (Applicable to Engineering/Bench Testing)

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

Test Set (Electrodes for Shelf Life/Dispersion):
- Dispersion Testing: 4 batches of electrodes. From each batch, 8 chest, 8 lateral back, 1 upper back, and 1 abdomen electrode were selected. (Total: 4 x (8+8+1+1) = 4 x 18 = 72 electrodes).
- Shelf Life Testing: 72 electrodes (from the same batches, implied).
Data Provenance: The testing was "bench testing" and conducted "in a climate cabinet" (for accelerated aging). The location (country of origin) is not explicitly stated for these specific tests but the manufacturer is based in Germany. The testing is prospective for the purpose of demonstrating compliance.

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

Not applicable in the human-expert-reader sense. The ground truth for this type of submission is defined by the compliance of the device's technical specifications and performance against recognized international and national standards (e.g., IEC, ISO, ASTM) and FDA guidance documents. These are objective engineering measurements and validations.

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

Not applicable. This refers to clinical study methodologies for interpreting results (e.g., medical image interpretation). The "test set" here refers to engineering measurements against predefined standards.

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 device is a powered muscle stimulator, not an AI-assisted diagnostic device. The submission does not involve human-in-the-loop diagnostic performance studies.

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

Not Applicable. This is not an algorithm-only diagnostic device. Its performance is related to its physical outputs (electrical impulses) and safety features.

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

For the engineering and safety performance, the "ground truth" is defined by established international and national standards (e.g., IEC 60601 series, ISO 14971, ASTM F1980-16) and FDA guidance documents.
- For current distribution: FDA's requirements for bench testing.
- For software: IEC 62304 and FDA guidance for software validation.
- For electrical safety/EMC: IEC 60601 series.
- For usability: IEC 62366-1 and FDA guidance.

8. The sample size for the training set:

Not Applicable. This device does not use an AI model that requires a "training set" in the machine learning sense. The software validation is for the device's operational firmware, not for an adaptive or learning algorithm.

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.

March 11, 2021

miha bodytec GmbH Felix Schweigert QA/RA Manager Siemensstr. 1 Gersthofen, 86368 Germany

Re: K201975

Trade/Device Name: miha bodytec II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, IPF Dated: December 9, 2020 Received: December 14, 2020

Dear Felix Schweigert:

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 (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.

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

Enclosure

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Indications for Use

510(k) Number (if known) K201975

Device Name miha bodytec II

Indications for Use (Describe)

miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:

· Re-educating muscles
· Relaxation of muscle spasm
· Retarding or preventing disuse muscle atrophy

Type of Use (Select one or both, as applicable)

X 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

Sponsor

Sponsor: miha bodytec GmbH Siemensstr. 1 86368 Gersthofen Germany
Contact Person: Felix Schweigert fs@miha-bodytec.de Germany: +49 821 45 54 92 - 22 US: +1 833 367 6442
Date Prepared: July 06, 2020
510(k) number: K201975

Device Name and Classification

Proprietary Name: miha bodytec II
Common/Usual Name: Powered muscle stimulator
Classification Name: Stimulator, Muscle, Powered (21 CFR 890.5850, Product Code NGX and IPF)

Predicate Device

Predicate Device: Primary: miha bodytec II, K182519 Secondary: Compex rehab, K090632

Intended Use

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.

miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:

Re-educating muscles
Relaxation of muscle spasm

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Retarding or preventing disuse muscle atrophy
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.

Device Description and Function

miha bodytec II must be used in a professional setting incl. professional sport setting and stationary in closed rooms (clinics, hospitals, nursing homes, doctor's offices, physical therapists' private offices). The device must be operated by a trainer who has received a full training from the manufacturer. Before the training, the trainer selects the accessories incl. electrodes in the correct size, applies the electrodes to the athlete/patient 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/patient 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.

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

Predicate Device Comparison

Characteristic	New Device	Primary predicatedevice	SecondaryPredicate Device	Similar /Different
510(k)Number	K201975	K182519	K090632	-

General

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Device Name,Model	miha bodytec II	miha bodytec II	Compex rehab	-
Manufacturer	miha bodytec GmbH	miha bodytec GmbH	Chattanoogah	-
RegulationNumber	890.5850	890.5850	890.5850	Similar.
Product code	NGX; IPF	NGX	IPF	Different.The subjectdevicecombinesbothproductcodes NGXand IPF ofthepredicatedeviceswithin thesameregulationnumber.
Indications forUse	miha bodytec II is amachine with electronicmuscle stimulationbased on EMStechnology. Regardingits use, the device isspecifically designed asan addition to othersports and for trainingmuscles.	miha bodytec II is amachine with electronicmuscle stimulationbased on EMStechnology. Regardingits use, the device isspecifically designed asan addition to othersports and for trainingmuscles. It must beused for healthymuscles and clients, notbe used forrehabilitation purposes.	The Compex®Rehab is anadjunctivemultifunctionelectrotherapydevice with varioustreatment modesthat allow forneuromuscularelectricalstimulation(NMES). TheCompex® Rehab isindicated for thefollowingconditions:	Similarbetweensubject andprimarypredicatedevice interms ofindicationsfor useNGX.Theprimarypredicatedevice doesnot coverthe IPFrelated
	miha bodytec II isintended to stimulatemuscles in order toimprove or facilitatemuscle performance. InAddition it is indicatedfor the followingconditions:- Re-educating muscles	miha bodytec II isintended to stimulatehealthy muscles inorder to improve orfacilitate muscleperformance. mihabodytec II is notintended to be used inconjunction with	- Re-educatingmuscles	therapeuticindications.Similarbetweensubject andsecondarypredicatedevice interms of
	- Relaxation of musclespasm	therapy or treatment ofmedical diseases or	- Relaxation ofmuscle spasm	indicationsfor use IPF.
- Retarding or	medical conditions of	- Increasing local	The
preventing disuse	any kind. None of the	blood circulation	secondary
muscle atrophy	miha bodytec II training	- Retarding or	predicate
The miha bodytec II	programs are designed	preventing disuse	device does
electrical impulses allow	for injured or ailing	atrophy	not cover
the triggering of action	muscles and its use on	- Maintaining or	the NGX
potentials on	such muscles is	increasing range of	related
motoneurons of motor	contraindicated.	motion	muscle
nerves (excitations).	The miha bodytec II		conditionin
These excitations of	electrical impulses allow		g
motoneurons are	the triggering of action		indications.
transmitted to the	potentials on
muscle fibers via the	motoneurons of motor		However,
motor endplate where	nerves (excitations).		despite the
they generate	These excitations of		differences
mechanical muscle fiber	motoneurons are		in
responses that	transmitted to the		indications,
correspond to muscle	muscle fibers via the		the general
work. Depending on the	motor endplate where		intended
parameters of the	they generate		use,
electrical impulses	mechanical muscle fiber		powered
(pulse frequency,	responses that		muscle
duration of contraction,	correspond to muscle		stimulator
duration of rest, total	work. Depending on the		for medical
session duration),	parameters of the		purposes,
different types of	electrical impulses		is the
muscle work can be	(pulse frequency,		same.
imposed on the	duration of contraction,		Moreover,
stimulated muscles.	duration of rest, total		the subject
	session duration),		device
	different types of		combines
	muscle work can be		both
	imposed on the		indications
	stimulated muscles.		and does
	The various types of		not add
	muscle work that the		additional
	miha bodytec II can		indications.
	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

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Connection of the device to electrodes	One stimulation module / control unit which is channel-wise connected to the i-body® electrodes over a cable to the i-body® vest. The electrodes of the i-body® straps and belt are connected via cables to the vest.	One stimulation module / control unit which is channel-wise connected to the i-body® electrodes over a cable to the i-body® vest. The electrodes of the i-body® straps and belt are connected via cables to the vest.	One stimulation module / control unit which is channel-wise connected to the respective electrodes	Similar electrode connection from a control unit to the attached electrodes
Power Source(s)	Control unit: 15 V - 19 V; External power supply (100 - 240 V ~ 50 - 60 Hz)	Control unit: 15 V - 19 V; External power supply (100 - 240 V ~ 50 - 60 Hz)	4.8 V (2000 mAh) NiMH rechargeable battery	No difference between subject and primary predicate device.Difference between subject and secondary predicate device. The external power supply of subject device was tested according to AAMI/ANSI ES 60601-1:2005/(R) 2012 and A1:2012. No new concerns regarding safety and effectivene ss were raised during verification
				andvalidation.
- Method ofLine CurrentIsolation	Power Supply inaccordance with IEC60601-1	Power Supply inaccordance with IEC60601-1	N/A (batteryoperated device)	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice. Seecommenton powersource.
- PatientLeakageCurrent	< 100 μΑ	< 100 μΑ	N/A (batteryoperated device)	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice. Seecommenton powersource.
- Normalcondition	< 100 μΑ	< 100 μΑ	N/A (batteryoperated device)	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice. Seecommenton powersource.
				subject andsecondarypredicatedevice. Seecommenton powersource.
- Single faultcondition	< 100 μΑ	< 100 μΑ	N/A (batteryoperated device)	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice. Seecommenton powersource.
Number ofOutput Modes	One (symmetricbiphasic) with 6 trainingprograms	One (symmetricbiphasic) with 6 trainingprograms	One (symmetricbiphasic)	Similar. Alldevicesprovideone outputsymmetricbiphasicoutputmode.
Number ofOutputChannels	10, channel selectivestimulation.Maximum one channelis active at any time.	10, channel selectivestimulation.Maximum one channelis active at any time.	Four independentand individuallyadjustablechannels that areelectrically isolatedfrom each other.	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.

				However, ahighernumber ofchannelsdoes notimposehigheroutputvalues. Itsimplymeans thatmoremusclesgroups canbestimulated.Besidethat,maximum 1channel isactive atany time.
- SynchronousorAlternating?	Alternating	Alternating	For 2-channelconfiguration,channels 1 and 2alternate.For 4-channelconfiguration,channels 1+2alternate withchannels 3+4.	Similar. Alldevicesprovide analternatingoutput.
- Method ofChannelIsolation	Multiplexed by controlunit	Multiplexed by controlunit	N/A	Nodifferencebetweensubject andprimarypredicatedevice.Correspondinginformation forsecondarypredicatedevice not
				publiclyavailable.
RegulatedCurrent orRegulatedVoltage?	Regulated voltage (allchannels)	Regulated voltage (allchannels)	Regulated current(all channels)	Nodifferencebetweensubject andprimarypredicatedevice.Differentregulationmechanismbetweensubject andsecondarypredicatedevice.However,both aresafe andeffectiveand complywith IEC60601-2-10.
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Similar
AutomaticOverloadTrip?	Yes, no load and shortcircuit conditions arehandled	Yes, no load and shortcircuit conditions arehandled	N/A	Nodifferencebetweensubject andprimarypredicatedevice.Correspondinginformationforsecondarypredicatedevice not
	Automatic No-Load Trip?			publiclyavailable.
	Yes, no load and shortcircuit conditions arehandled	Yes, no load and shortcircuit conditions arehandled	N/A	Nodifferencebetweensubject andprimarypredicatedevice.Correspondinginformation forsecondarypredicatedevice notpubliclyavailable.
AutomaticShut Off?	On/Off-Switch,stimulation stops afterdefined duration,automatic stop ofstimulation in case offailure / malfunctiondetected	On/Off-Switch,stimulation stops afterdefined duration,automatic stop ofstimulation in case offailure / malfunctiondetected	On/Off button tointerrupt theprogrammemomentarily,stimulation stopsafter definedduration,automatic stop ofstimulation in caseof failure /malfunctiondetected throughregular automaticperformancechecks duringoperation	Similar. Alldevicesprovide ahardwareon/off-switch aswell aserrormonitoringimplemented in thefirmware.
PatientOverrideControl?	Yes, while a program isactive theathlete/patient issupervised by a trainerand able to manipulateintensity (amplitude)and push the stopbutton	Yes, while a program isactive theathlete/patient issupervised by a trainerand able to manipulateintensity (amplitude)and push the stopbutton	Operation only byauthorizedindividuals. Choiceof therapyparameters,programs andprotocols only byresponsiblephysician ortherapist. During	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andpredicate.
			training not alwayssupervised. Only ifpatients are unableto operate theemergency stopfunction.	secondarydevice,becausesupervisionduringtraining isnot alwaysmandatoryfor thesecondarydevice.However, acontinuoussupervisionof a traineris expectedto increasethe safetyof thedevice.
IndicatorDisplay:	Yes	Yes	Yes	Similar, alldevicesprovide adisplay.
- On/OffStatus?	Yes	Yes	Yes	Similar, alldevicesshow theon/offstatus.
- Low Battery?	N/A, no battery	N/A, no battery	Yes	Different.Notapplicableto subjectandprimarypredicatedevicesince nobattery isused.
- Voltage/Current Level?	Yes, displayed in form ofpercentage / valuerange	Yes, displayed in form ofpercentage / valuerange	Yes, displayed inform of black bargraphs	Similar, alldevicesdisplay thevoltage /
				currentlevel.
Timer Range /ProgramDuration(minutes)	Training should notexceed 20 minutes;Screen shows remainingtime in minutes anddisplays image showingtime remaining	Training should notexceed 20 minutes;Screen shows remainingtime in minutes anddisplays image showingtime remaining	Maximum = 20minutes (for theprograms referredto for substantialequivalencediscussion); Screenshows remainingtime in horizontalbars	Nodifferencebetweensubject andpredicatedevices.
Number ofPrograms	6 programs	6 programs	22	Nodifferencebetweensubject andprimarypredicatedevice.Thesecondarypredicatedeviceoffers moreprograms.However,with theprogramsprovidedby thesubjectdevice, theindicationsstated arecovered
User Interface	Physical buttons androtary knobs withpictographs of thetrained muscles for aquick und usability-oriented setting of theintensity values andmulti-functional buttonfor setting, programselection and	Physical buttons androtary knobs withpictographs of thetrained muscles for aquick und usability-oriented setting of theintensity values andmulti-functional buttonfor setting, programselection andSTART/STOP for	The device isequipped with akeypad composedof push buttonswhich are locatedbelow the LCD. Thefunction for eachbutton is definedby a symbol on theLCD corresponding	Subject andprimarypredicatedevice areidentical.Differencebetweensubject andsecondarypredicatedevice.
	immediate stimulationstop, power-off button,RFID transponder cardplacement area.10.1 inch non-touch LCcolor display forprogram / training planselection via menu,settings, device status ,training mode display(animated avatar, timer,selected program)	immediate stimulationstop, power-off button,RFID transponder cardplacement area.10.1 inch non-touch LCcolor display forprogram / training planselection via menu,settings, device status ,training mode display(animated avatar, timer,selected program)	to the buttonimmediatelybelow it.The displayis a graphic displaycapable of showingalpha numericcharacters(including lowercase characters),moststandard ASCIIsymbols, andgraphicsappropriate toassist the user inselecting adesirable program.TheLCD is used todisplay systeminformation to theuser.	However,subjectdeviceprovides alargerdisplay forchangingsettings,choosingprograms /trainingplans, andprovidingrelevantinformation duringtraining.The UI ofmihabodytecwas testedfor usabilityaccordingto FDA'sguidance.
Portability /Mobile Use	Portable with difficulty,no mobile device, itsintended use requiresthe qualified andtrained operator.	Portable with difficulty,no mobile device, itsintended use requiresthe qualified andtrained operator.	Mobile device	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarydevice.
Operator	The device must only beoperated by a trainer,who received fulltraining by mihabodytec.	The device must only beoperated by a trainer,who received fulltraining by mihabodytec.	Only authorisedindividuals areallowed to operatethe device.Individuals areauthorised afterreceiving training inthe operation ofthe unit andreading thisoperating onmanual.	Similar.Bothdevicesrequireoperationby aqualifiedoperatorwhoreceived atraining incorrespond

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Compliancewith 21 CFR 898?(Mandatory since May 9, 2000)	Yes	Yes	Yes	ing operation.Similar
Size of electrodes	Electrodes with pre-defined size of 9.75 – 64.36 in², 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 size of 9.75 – 64.36 in², 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 from 3,88 in² to 7,78 in².Length x Width of electrode pads:1,97 in x 1,97 – 3,94 in	Same size between subject and primary predicate device.Electrodes have been cleared under K182519.Difference between subject and secondary predicate. However, electrodes of subject device are bigger which leads to less current density and therefore to lower severity in case of harm.
Vest size	Size 1 and size V1 in in²2 electrodes for abdomen	Size 2, size 3 and size v2 in in²	Vest size	Size 1 and size V1 in in²2 electrodes for abdomen	Size 2, size 3 and size v2 in in²
	22.85	27.56		22.85	27.56
	2 electrodes for chest			2 electrodes for chest
	10.31	12.81		10.31	12.81
	2 electrodes for upper back			2 electrodes for upper back
	16.25	20.98		16.25	20.98
	2 electrodes for sides of back			2 electrodes for sides of back
	9.75	11.85		9.75	11.85
	2 electrodes for lower back			2 electrodes for lower back
	14.4	19.47		14.4	19.47
	Strap sizeSize 1 (pair)Size 2 (pair)Size 3 (pair)	Electr. size in²Each 34.15Each 48.77Each 64.36		Strap sizeSize 1 (pair)Size 2 (pair)Size 3 (pair)	Electr. size in²Each 34.15Each 48.77Each 64.36
	Strap sizeSize 1 (pair)	Electr. size in²Each 14.7		Strap sizeSize 1 (pair)	Electr. size in²Each 14.7

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	Size 2 (pair)	Each 18.34	Size 2 (pair)	Each 18.34
Plugs	Main cable with D-Sub25 pin connector to thecontrol unit andproprietary magneticconnector to the i-bodyvest. Cables betweenvest and strap / beltwith proprietaryconnectors.	Main cable with D-Sub25 pin connector to thecontrol unit andproprietary magneticconnector to the i-bodyvest. Cables betweenvest and strap / beltwith proprietaryconnectors.	Cables connect tothe electrodes withsnap fastener andconnect to themachine with ahigh friction, andforced fitting,mechanicallyshielded connector.	Identicalbetweensubject andprimarypredicatedevice.Differentplug designbetweensubject andsecondarypredicatedevice.Howeverbothdeviceshave beensuccessfullytestedaccordingto therelevantrecognizedsafetystandards(IEC60601).
Lead wires -cables	1. Main cable with D-Sub 25 pin connector tothe control unit andproprietary magneticconnector to the i-bodyvest. Length: 3000 mm,Polyurethane jacket.2.1-pole-cablesbetween vest and strap/ belt: 15,75 in, 19,29 in,30,71 in, PVC jacket.3. Cables within vest:firmly mounted into thevest; PolyurethanejacketCompliant with	1. Main cable with D-Sub 25 pin connector tothe control unit andproprietary magneticconnector to the i-bodyvest. Length: 3000 mm,Polyurethane jacket.2.1-pole-cablesbetween vest and strap/ belt: 15,75 in, 19,29 in,30,71 in, PVC jacket.3. Cables within vest:firmly mounted into thevest; PolyurethanejacketCompliant with	Each of the four0,083 inch leadwires will connectthe output of thestimulator to eachof the electrodesfor eachrespective outputchannel.These cablesconnect to theelectrodes withsnap fastener andconnect to themachine with ahigh friction, andforced fitting,mechanicallyshielded connector.	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevicebecausethe cableleads fromthe controlunitdirectly tothe electrodes.
	patient cable safetyrequirements	patient cable safetyrequirements		electrodesof thesecondarypredicatedevice.However,bothdeviceshave beensuccessfullytestedaccordingto therelevantrecognizedsafetystandards(IEC60601).
Conductivityof theelectrodes	The athlete/patientneeds to put on thegenuine andbiocompatible mihabodytec undergarments(pants and shirt) underthe i-body accessories(vest, strap and belt).The absorbentelectrodes covers onthe i-body vest, strapand belt need to bemoistened using apump spray bottle withtap water.The electrode vest,straps and belt arewashable.	The athlete needs toput on the genuine andbiocompatible mihabodytec undergarments(pants and shirt) underthe i-body accessories(vest, strap and belt).The absorbentelectrodes covers onthe i-body vest, strapand belt need to bemoistened using apump spray bottle withtap water.The electrode vest,straps and belt arewashable.	Limited usage, gel-coveredelectrodes. Aftersomeusage, the qualityof theelectrodes,resistance andadherence willdepend onthe user's skintype.The electrodes areself-adhesive andneed to beattached directly tothe skin. They donot need to bemoistened and arenot allowed to beused on differentpatients due todirect skin contact	Nodifferencebetweensubject andprimarypredicatedevice.Electrodeshave beenclearedunderK182519.Differencebetweensubject andsecondarydevice.However,bothapproachesareeffective.Thedifferenceof mihabodytec IIis that theelectrodesmust bemoistened
				with waterand do nothave anydirect skincontact.
Placement ofthe electrodes	Appropriately pre-placedin specific areasaccordingto muscle anatomy.Electrodes are firmlymounted into the vest,belt or straps. Theelectrodes itself cannotbe separated from thetextile and cannot beexchanged.	Appropriately pre-placedin specific areasaccordingto muscle anatomy.Electrodes are firmlymounted into the vest,belt or straps. Theelectrodes itself cannotbe separated from thetextile and cannot beexchanged.	The singleindividualelectrodes are notpre-placed in anykind and can beapplied on any areaof the body	Nodifferencebetweensubject andprimarypredicatedevice.Electrodeshave beenclearedunderK182519.Differencebetweensubject andsecondarydevice.However,with mihabodytec IIthere is norisk ofincorrectelectrodeplacementby mistake.
Material ofelectrodes	The conductiveelectrode itself (underthe textile) is made outof a 100% BEKINOXStainless Steelmultifilament yarn.No direct skin contactpossible.	The conductiveelectrode itself (underthe textile) is made outof a 100% BEKINOXStainless Steelmultifilament yarn.No direct skin contactpossible.	Direct skin contact.Furtherinformation notpublicly available.	Nodifferencebetweensubject andprimarypredicatedevice.Electrodeshave beenclearedunderK182519.
Maximumduration for	Max. 20 minutes pertreatment.	Max. 20 minutes pertreatment.	Maximum = 20minutes (for theprograms referred	Nodifferencebetween
use pertreatment				subject andpredicatedevices.
Accessories	i-body vesti-body strapi-body beltUndergarmentsTransponder card	i-body vesti-body strapi-body beltUndergarmentsTransponder card	Bags of smallelectrodes(5x5 cm 1 snapconnection)2 bags of largeelectrodes(5x10 cm 2 snapconnections)Set of 4 pin cablesSnap adaptor kitMotor point pen	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.Thesecondarypredicatedeviceneedsadditionalaccessoriesforelectrodeplacement.
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: 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: N/AControl unit: 0,66lb (batteryincluded)Accessory: N/A	Nodifferencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.
Dimensions(ft.) [W x H xD]	Control unit: 1.39 × 0.89× 0.23 (W × D × H in ft)Complete: 1.77 × 1.69 ×3.89 (W × D × H in ft)	Control unit: 1.39 × 0.89× 0.23 (W × D × H in ft)Complete: 1.77 × 1.69 ×3.89 (W × D × H in ft)	Control unit: 0.45 ×0.31 × 0.11 (W × D× H in ft)	Nodifferencebetweensubject andprimary
				predicate device. Difference between subject and secondary predicate device.
Housing Materials and Construction	Control unit:Aluminum	Control unit:Aluminum	Control unit:plastic	No difference between subject and primary predicate device. Different housing material between subject and secondary predicate device. However, both devices have been successfully tested according to the relevant recognized safety standards (IEC 60601).
Standards	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 And A1:2012IEC 60601-1-2:2014IEC 60601-1-11:2015IEC 60601-2-10:2016IEC 62304:2006 + A1:2015	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 And A1:2012IEC 60601-1-2:2014IEC 60601-1-11:2015IEC 60601-2-10:2016IEC 62304:2006 + A1:2015	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	Similar.

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IEC 62366-1:2015 +COR1:2016ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010ASTM F1980-16	IEC 62366-1:2015 +COR1:2016ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010ASTM F1980-16
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Table 1: Basic Device Characteristics – Comparison with Predicate Device

Output Specifications

Characteristic	New Device	Primary PredicateDevice	SecondaryPredicate Device	Similar /Different
Waveform	Symmetric biphasic	Symmetric biphasic	Symmetricbiphasic	Similar output
Shape	Rectangular	Rectangular	Rectangular	Similar shape
MaximumOutput Voltage	<= 74Vp @ 500Ω (54 -74 Vp)<= 152Vp @ 2kΩ (110... 152 Vp)<= 152Vp @ 10kΩ(130 ... 152 Vp)	<= 74Vp @ 500Ω (54 -74 Vp)<= 152Vp @ 2kΩ (110... 152 Vp)<= 152Vp @ 10kΩ (130... 152 Vp)	60V @ 500Ω	No differencebetweensubject andprimarypredicatedevice.Differentmaximumoutput valuesbetweensubject andsecondarypredicatedevice.However, thisdoes not raisenew questionsregardingsafety andeffectivenesssince bothdevicescomply andare within thelimits of IEC60601-2-10.
MaximumOutput Current	< 148mAp @ 500Ω(108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ(13-15mAp)	< 148mAp @ 500Ω(108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ (13-15mAp)	120mA @ 500Ω	No differencebetweensubject andprimarypredicatedevice.Differentmaximumoutputcurrentbetweensubject andsecondarypredicatedevice.However, thisdoes not raisenew questionsregardingsafety andeffectivenesssince bothdevicescomply andare within thelimits of IEC60601-2-10.
Pulse Width	50 - 400 μs	50 - 400 μs	30 - 400 μs	Similar pulsewidth.
Frequency (Hz)	2 - 150 Hz	2 - 150 Hz	1 - 150 Hz	Similarfrequency.
Symmetricalphases?	Yes	Yes	Yes	Similar.
Phase Duration	25 ... 200 μs	25 ... 200 μs	15 ... 200 μs	Similar phaseduration
MaximumPhase Charge	<32 μC @ 500Ω	<32 μC @ 500Ω	48 μC @ 500Ω	No differencebetweensubject andprimarypredicatedevice.
				Differentmaximumphase chargebetweensubject andsecondarypredicatedevice.However,subject devicevalue is lowerthan the valueof thesecondarypredicatedevice.
MaximumCurrentDensity	0.64 mA/cm² @ 500Ω	0.64 mA/cm² @ 500Ω	1,18 mA/cm² @500Ω	No differencebetweensubject andprimarypredicatedevice.Differentmaximumcurrentdensitybetweensubject andsecondarypredicatedevice.However, alldevices fulfilltherequirementsof IEC 60601-2-10 becausethe values arewithin thelimit of 2mA/cm².
MaximumPower Density	0.82 mW/cm² @500Ω	0.82 mW/cm² @ 500Ω	N/A	No differencebetweensubject andprimary

				predicatedevice.Correspondinginformationfor secondarypredicatedevice notpubliclyavailable.
Burst Mode	Contraction time: 1 -10 sRelaxation time: 0.0 -10 s	Contraction time: 1 -10 sRelaxation time: 0.0 -10 s	N/A	No differencebetweensubject andprimarypredicatedevice.Correspondinginformationfor secondarypredicatedevice notpubliclyavailable.
Safety circuits	Short-circuitmonitoring, watchdogmonitoring, no loadtrip, onload trip,button for immediateshut off, redundanthardware errormonitoring(emergency STOPoption)Firmware self-tests.	Short-circuitmonitoring, watchdogmonitoring, no loadtrip, onload trip,button for immediateshut off, redundanthardware errormonitoring(emergency STOPoption)Firmware self-tests.	N/A	No differencebetweensubject andprimarypredicatedevice.Correspondinginformationfor secondarypredicatedevice notpubliclyavailable.

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Table 2: Output Specifications – Comparison with Predicate Devices

Performance Testing

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.

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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.

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 abdomen-electrode (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 F1980-16. 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

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

. IEC 60601-2-10:2016 - 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 60601-1-11:2015 - 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 62304:2006 + A1:2015 - Medical Device Software - Software Life Cycle Processes
ISO 14971:2007 - Medical Devices - Application Of Risk Management To Medical Devices

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. IEC 62366-1:2015 + COR1:2016 - 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
. ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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 27, 2019

Conclusion

All features and technological characteristics of the subject and primary predicate device are identical, despite the indications for use. Electrodes have been cleared under K182519. Miha bodytec II has similar indications for use as the primary and the secondary predicate device combined and similar technological characteristics and features as the secondary predicate device. All 3 devices use wired connections between the control unit to the electrodes. Miha bodytec II and the primary predicate device use the same specifically designed biocompatible undergarment and electrode connector accessories which are placed on the undergarment and not directly on the skin while the secondary predicate device uses self-adhesive electrodes which get placed directly on the skin.

The devices have slightly different output specifications, cable specifications, however, all within the limits given by IEC 60601-2-10 and in compliance with IEC 60601-1 and IEC 60601-1-2. Both miha bodytec II and the primary predicate device are powered by line voltage, whereas the Compex Rehab 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.

miha bodytec II provides a slightly different user interface with an integrated 10.1 inch display. Usability tests for miha bodytec II have been successfully conducted following FDA's guidance.

None of these differences raise any new issues regarding safety or effectiveness. Therefore, we conclude that miha bodytec II is substantially equivalent to the primary predicate device miha bodytec II as well as the secondary predicate device Compex Rehab.

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).