miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. 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 of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

miha bodytec II may only be used by persons above the age of 21.

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 device encompasses the following variants:

"Miha bodytec II" control unit connected to the electrodes via cable
"Miha bodytec II" control unit connected via Bluetooth through the "i-body connect wireless" device"
"Miha bodytec m.ove" control unit for mobile use connected via Bluetooth through the "i-body connect wireless" device"

The "miha bodytec m.ove" is a lighter version of the "miha bodytec II" device. Almost all electrical components and circuit boards are identical. It shall mainly be used as a mobile solution either with "travel station m.ove" or with "work station m.ove" in medical facilities. It must be connected with the electrode system via the additional wireless stimulation equipment "i-body connect wireless" and has no cable connection.

The "travel station m.ove" is an equipment for the "miha bodytec m.ove" device (not for miha bodytec II) and is supposed to be used as a mobile solution for personal trainers all around the world. It will be used as a "bag" or "suitcase" where the device and the electrodes can be safely stored while travelling and will be used as a stand while the training with the customer is in progress. It has no electronics built in and is mainly made out of textiles, plastics and aluminum.

The "work station m.ove" is an additional equipment for the "miha bodytec m.ove" (not for miha bodytec II) and is supposed to be mainly used in hospitals, physiotherapy facilities and homes for the elderly. It will be used as a transport solution where the device and the electrodes can be safely stored while moving through the facilities and will be used as a stand while the training with the patient is in progress. It has no electronics built in and is mainly made out of wood, plastics and aluminum/steel.

The "i-body connect wireless" is a portable device, which is supposed to be worn at the patient's body. It has a built in stimulation circuit board and a Bluetooth receiver and produces the stimulation itself while the main device only acts as a remote control. This way a wireless training / treatment of the trainee / patient is possible. On the one hand, it is a mandatory equipment for the "miha bodytec m.ove" device due to the missing cable connection. On the other hand, it is an additional equipment for the "miha bodytec II" device, which can be used instead of the main connection cable. Through a corresponding software update, the second generation of the device (primary predicate device, K201975) can be changed into a third generation version (subject device, K221498), enabling the wireless functions of the device and thus compatibility with the i-body connect wireless.

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 in the correct size, applies the electrodes to the athlete/patient i.e. by wearing the electrode vest and connects the straps and belt via cable to the vest and via the "i-body connect wireless" device to the control unit. The trainer can choose between several training programs on the control unit for impulse familiarization 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 wirelessly to the "i-body connect wireless" device and thus to the electrodes. 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.

AI/ML Overview

This document is a 510(k) summary for the Miha Bodytec II, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria in the typical sense of a clinical trial for diagnostic devices. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies (MRMC) would not be found in this type of submission.

The "acceptance criteria" and "reported device performance" provided are primarily related to safety, electrical output specifications, and regulatory compliance, demonstrating that the device functions as intended within established safety limits and industry standards.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is derived from the "Output Specifications" table (Table 2) and the "Performance Testing" section. Due to the nature of a 510(k) for a powered muscle stimulator, the "acceptance criteria" are generally compliance with international safety standards and performance within specified technical ranges, rather than clinical efficacy metrics like sensitivity or specificity.

Characteristic	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance
Waveform	Symmetric biphasic (matching predicate)	Symmetric biphasic
Shape	Rectangular (matching predicate)	Rectangular
Max Output Voltage	Within ranges comparable to predicate devices	miha bodytec II (cable): ≤ 74Vp @ 500Ω, ≤ 152Vp @ 2kΩ, ≤ 152Vp @ 10kΩ miha bodytec II (wireless): ≤ 76.2Vp @ 500 Ω, ≤ 111Vp @ 2 kΩ, ≤ 117Vp @ 10 kΩ miha bodytec m.ove: ≤ 76.2Vp @ 500 Ω, ≤ 111Vp @ 2 kΩ, ≤ 117Vp @ 10 kΩ
Max Output Current	Within ranges comparable to predicate devices	miha bodytec II (cable): < 148mAp @ 500Ω, < 76mAp @ 2kΩ, < 15 mAp @ 10kΩ miha bodytec II (wireless): < 152.4mAp @ 500 Ω, < 55.5mAp @ 2 kΩ, < 11.7mAp @ 10 kΩ miha bodytec m.ove: < 152.4mAp @ 500 Ω, < 55.5mAp @ 2 kΩ, < 11.7mAp @ 10 kΩ
Pulse Width	50 - 400 µs (matching primary predicate)	50 - 400 µs
Frequency (Hz)	Cable: 2 - 150 Hz (matching primary predicate) Wireless: 2 - 100 Hz	miha bodytec II (cable): 2 - 150 Hz miha bodytec II (wireless): 2 - 100 Hz miha bodytec m.ove: 2 - 100 Hz
Symmetrical Phases	Yes (matching predicate)	Yes
Phase Duration	25 - 200 µs (matching primary predicate)	25 - 200 µs
Maximum Phase Charge	Comparable to predicate devices	miha bodytec II (cable): <32 µC @ 500Ω miha bodytec II (wireless): < 30.48 µC @ 500Ω miha bodytec m.ove: < 30.48 µC @ 500Ω
Maximum Current Density	Comparable to predicate devices	miha bodytec II (cable): 0.64 mA/cm² @ 500Ω miha bodytec II (wireless): 0.42 mA/cm² @ 500 Ω miha bodytec m.ove: 0.42 mA/cm² @ 500 Ω
Maximum Power Density	Comparable to predicate devices	miha bodytec II (cable): 0.82 mW/cm² @ 500Ω miha bodytec II (wireless): 5.47 mW/cm² @ 500 Ω miha bodytec m.ove: 5.47 mW/cm² @ 500 Ω
Burst Mode	Contraction: 1 - 10 s, Relaxation: 0.0 - 10 s (matching primary predicate)	Contraction time: 1 - 10 s, Relaxation time: 0.0 - 10 s
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-2-10	Tested according to and in compliance with recognized standards.
EMC	Compliance with IEC 60601-1-2	Tested according to and in compliance with recognized standards.
Software Validation	Compliance with IEC 62304 and FDA guidance	Verified and validated; met software system requirements, full system validation including FDA "Guidance Document for Powered Muscle Stimulator 510(k)s" recommendations.
Usability Validation	Device meets intended use safely and effectively by specified users	Overall system validated to confirm safe and effective use.
Electrode Uniform Current	Uniform current distribution (dispersion testing)	Bench testing performed (4 batches, 8 lateral back, 1 upper back, 1 abdomen electrode per batch; 8 measure points per chest/back, 5 per abdomen). All tests successfully passed.
Electrode Shelf Life	3-year storage demonstrated	Accelerated aging at 60°C for 10 weeks simulated for 3-year storage. 10 electrodes and 6 contact points tested. All tests successfully passed.

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

Sample Size for Dispersion Testing: 4 batches of electrodes. From each batch, 8 lateral back-electrodes, 1 upper back-electrode, and 1 abdomen-electrode were selected. Specific numbers of measurement points were defined (8 points from each chest/lateral/upper back electrode, 5 points from each abdomen electrode).
Sample Size for Shelf Life Testing: 10 electrodes and 6 contact points.
Data Provenance: The nature of these tests (bench testing, climate chamber simulation) indicates they were conducted in a laboratory setting, likely in Germany, given the manufacturer's location. The tests are "retrospective" in the sense that they are conducted on manufactured components to verify design specifications, not on real-world patient data.

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

Not applicable for this type of submission. The tests performed are engineering and electrical measurements, and compliance with standards. Ground truth for device performance in this context is established by the specifications in the standards themselves and the measurable physical outputs and characteristics of the device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic evaluations where interpretative differences between human readers need to be resolved. The tests described are objective physical and electrical measurements.

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-powered diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The "Performance Testing" section describes validation of the firmware and electrical output characteristics, which can be considered a form of standalone performance evaluation for the device's electrical functions. This involves oscilloscope tracings of output waveforms and other electrical/thermal tests. The term "algorithm only" is not appropriate as this is a hardware device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance tests described:

Electrical Safety and EMC: Ground truth is defined by the limits and methodologies specified in the cited international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10).
Software and System Validation: Ground truth is defined by the software system requirements document and the specifications in the "Guidance Document for Powered Muscle Stimulator 510(k)s" and IEC 62304.
Bench Testing of Electrodes: Ground truth for uniform current distribution (dispersion) and electrical resistance for shelf life is based on the device's design specifications and the FDA's requirements for such tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in that context. The "software" refers to firmware for device control, validated through traditional software engineering processes.

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

Not applicable, as there is no "training set" in the machine learning sense.

Summary

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October 7, 2022

Miha Bodytec GmbH Felix Schweigert QA/RA Manager Siemensstr. 1 Gersthofen. 86368 Germany

Re: K221498 Trade/Device Name: Miha Bodytec II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Dated: September 8, 2022 Received: September 8, 2022

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221498

Device Name miha bodytec II

Indications for Use (Describe)

miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. 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

miha bodytec II may only be used by persons above the age of 21.

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 GmbHSiemensstr. 186368 GersthofenGermany
Contact Person:	Felix Schweigertfs@miha-bodytec.de+49 821 45 54 92 - 22

Date Prepared: September 8, 2022
510(k) number: K221498

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, K201975 Secondary: Katalyst Training System, K190966

Intended Use

miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. 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

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miha bodytec II may only be used by persons above the age of 21.

Device Description and Function

The device encompasses the following variants:

"Miha bodytec II" control unit connected to the electrodes via cable ।
। "Miha bodytec II" control unit connected via Bluetooth through the "i-body connect wireless" device"
-"Miha bodytec m.ove" control unit for mobile use connected via Bluetooth through the "i-body connect wireless" device"

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the main device only acts as a remote control. This way a wireless training / treatment of the trainee / patient is possible. On the one hand, it is a mandatory equipment for the "miha bodytec m.ove" device due to the missing cable connection. On the other hand, it is an additional equipment for the "miha bodytec II" device, which can be used instead of the main connection cable. Through a corresponding software update, the second generation of the device (primary predicate device, K201975) can be changed into a third generation version (subject device, K221498), enabling the wireless functions of the device and thus compatibility with the i-body connect wireless.

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.

Characteristic	New Device	Primary predicate device	Secondary Predicate Device	Similar / Different
510(k) Number	K221498	K201975	K190966	-
Device Name, Model	miha bodytec II (3rd generation)	miha bodytec II (2nd generation)	Katalyst Training System	-
Manufacturer	miha bodytec GmbH	miha bodytec GmbH	Katalyst Inc.	-
Regulation Number	890.5850	890.5850	890.5850	Similar.
Product code	NGX; IPF	NGX; IPF	NGX	Similar between subject and primary predicate device. The Secondary Predicate Device only contains one of the product codes due to its limited indications for use.

Predicate Device Comparison

Conoral

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Indications for Use
miha bodytec II (MBT II) is amachine with electronicmuscle stimulation basedon EMS technology.Regarding its use, thedevice is specificallydesigned as an addition toother sports and for trainingmuscles.miha bodytec II is intendedto stimulate muscles inorder to improve or facilitatemuscle performance. Inaddition it is indicated forthe following conditions:- Re-educating muscles- Relaxation of musclespasm- Retarding or preventingdisuse muscle atrophyThe miha bodytec IIelectrical impulses allow thetriggering of actionpotentials on motoneuronsof motor nerves(excitations). Theseexcitations of motoneuronsare transmitted to themuscle fibers via the motorendplate where theygenerate mechanicalmuscle fiber responses thatcorrespond to muscle work.Depending on theparameters of the electricalimpulses (pulse frequency,duration of contraction,duration of rest, totalsession duration), differenttypes of muscle work canbe imposed on thestimulated muscles.	miha bodytec II (MBT II) is amachine with electronicmuscle stimulation basedon EMS technology.Regarding its use, thedevice is specificallydesigned as an addition toother sports and for trainingmuscles.miha bodytec II is intendedto stimulate muscles inorder to improve or facilitatemuscle performance. Inaddition it is indicated forthe following conditions:- Re-educating muscles- Relaxation of musclespasm- Retarding or preventingdisuse muscle atrophyThe miha bodytec IIelectrical impulses allow thetriggering of actionpotentials on motoneuronsof motor nerves(excitations). Theseexcitations ofmotoneuronsare transmitted to themuscle fibers via the motorendplate where theygenerate mechanicalmuscle fiber responses thatcorrespond to muscle work.Depending on theparameters of the electricalimpulses (pulse frequency,duration of contraction,duration of rest, totalsession duration), differenttypes of muscle work canbe imposed on thestimulated muscles.	The Katalyst TrainingSystem is an Over-The-Counter device intendedto stimulate healthymuscles in order toimprove or facilitatemuscle performance. Itis to be used by adultsonly.The Katalyst TrainingSystem is not intendedto be used inconjunction with therapyor treatment of medicaldiseases or medicalconditions of any kind.None of the trainingprograms or operationalparameters aredesigned to targetinjured or ailing musclesand its use on suchmuscles iscontraindicated. TheKatalyst TrainingSystem's electricalimpulses allow thetriggering of actionpotentials onmotoneurons of motornerves (excitations).These excitations ofmotoneurons aretransmitted to themuscle fibers via themotor endplate wherethey generatemechanical muscle fiberresponses thatcorrespond to musclework. Depending on theparameters of theelectrical impulses(pulse frequency,duration of contraction,duration of rest, totalsession duration),different types of musclework can be imposed onthe stimulated muscles.	Similar betweensubject andprimarypredicatedevice.Similar betweensubject andsecondarypredicatedevice in termsof indicationsfor use relatedto the productcode NGX. Thesecondarypredicatedevice doesnot have listedthe IPF relatedmuscleconditioningindications.
Connection ofthe device toelectrodes
miha bodytec II (connectionvia cable): One stimulationmodule / control unit whichis channel-wise connectedto the i-body® electrodesover a cable to the i-body®vest. The electrodes of thei-body® straps and belt areconnected via cables to thevest.miha bodytec II (connectionvia i-body connectwireless):The body worn i-body	via i-body connectwireless):The body worn i-bodyconnect wireless is	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.		The Impulse Packconnects to the Suitthrough output cablesthat terminate with pogopin connectors. The Suitcontains an embeddedcable harness whichmakes connection withthe built-in electrodes.Neither the cableharness or theelectrodes areremovable. The Suitalso features leads with	electrodes areremovable. The Suitalso features leads withsnap connectors for	Similar betweenmiha bodytec II(connection viacable) andprimarypredicatedevice.Similar betweenmiha bodytec II(connection viai-body connectwireless)/mihabodytec m.ove	i-body connectwireless)/mihabodytec m.oveand secondary

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	controlled by the mihabodytec II via Bluetooth andconnects to the i-body vestthrough a short cable. Theelectrodes of the i-body®straps and belt areconnected via cables to thevest.miha bodytec m.ove:The body worn i-bodyconnect wireless iscontrolled by the mihabodytec m.ove viaBluetooth and connects tothe i-body vest through ashort cable. The electrodesof the i-body® straps andbelt are connected viacables to the vest.	connecting to the armelectrodes	predicatedevice.
PowerSource(s)	miha bodytec II:Control unit: 15 V – 19 V;External power supply (100– 240 V ~ 50 – 60 Hz)miha bodytec m.ove:Lithium Ion (Li-Ion)rechargeable battery14.4V, 6900 mAh; Usage viaexternal power supplypossible as well (100 – 240V ~ 50 – 60 Hz)i-body connect wireless:Lithium Ion (Li-Ion)rechargeable battery7.2V, 2900 mAh	Lithium Polymer (Li-Po)rechargeable battery7.4V, 2,050 mAh	No differencebetween mihabodytec II andprimaypredicatedevice.Differencebetweenbatteries ofmiha bodytecm.ove/i-bodyconncectwireless andsecondarypredicatedevice due tohigher power.
- Method ofLine CurrentIsolation	miha bodytec II:Power Supply in accordancewith IEC 60601-1miha bodytec m.ove:N/A (battery operateddevice);Usage with power supply:Power Supply inaccordance with IEC60601-1i-body connect wireless:N/A (battery operateddevice)	N/A (battery operateddevice)	Similar betweenmiha bodytec IIand primarypredicatedevice.Similar betweenmiha bodytecm.ove/i-bodyconnectwireless andsecondarypredicatedevice.
- PatientLeakageCurrent	miha bodytec II:< 100 μAmiha bodytec m.ove:N/A (battery operateddevice);Usage with power supply:< 100 μAi-body connect wireless:N/A (battery operateddevice)	< 100 μA	Similar betweenmiha bodytec IIand primarypredicatedevice.Similar betweenmiha bodytecm.ove/i-body connectwireless and
				secondarypredicatedevice.
- Normalcondition	miha bodytec II:< 100 μAmiha bodytec m.ove:N/A (battery operateddevice);Usage with power supply:< 100 μAi-body connect wireless:N/A (battery operateddevice)	< 100 μA	N/A (battery operateddevice)	Similar betweenmiha bodytec IIand primarypredicatedevice.Similar betweenmiha bodytecm.ove/i-bodyconnectwireless andsecondarypredicatedevice.
- Singlefaultcondition	miha bodytec II:< 100 μAmiha bodytec m.ove:N/A (battery operateddevice);Usage with power supply:< 100 μAi-body connect wireless:N/A (battery operateddevice)	< 100 μA	N/A (battery operateddevice)	Similar betweenmiha bodytec IIand primarypredicatedevice.Similar betweenmiha bodytecm.ove/i-bodyconnectwireless andsecondarypredicatedevice.
- Number ofOutputModes	One (symmetric biphasic)with 6 training programs	One (symmetric biphasic)with 6 training programs	One (NMES)	Similar.
- Number ofOutputChannels	miha bodytec II (connectionvia cable):10, channel selectivestimulation.Maximum one channel isactive at any time.miha bodytec II (connectionvia i-body connectwireless):8, Maximum one channel isactive at any time.miha bodytec m.ove:8, Maximum one channel isactive at any time.	10, channel selectivestimulation.Maximum one channel isactive at any time.	13	No differencebetween mihabodytec II(connection viacable) withprimarypredicatedevice.Difference of allvariants incomparisonwith secondarypredicatedevice.
- SynchronousorAlternating?	Alternating	Alternating	Synchronous, but never2 channels activated atthe same time	Similar
- Method ofChannelIsolation	Multiplexed by control unit	Multiplexed by control unit	Multi-Channel HighVoltage AnalogSwitches. Except duringchannel activation, each	Similar.
			channel is always inhigh Z state
RegulatedCurrent orRegulatedVoltage?	miha bodytec II (connectionvia cable):Regulated voltage (allchannels)miha bodytec II (connectionvia i-body connectwireless):Regulated current (all	Regulated voltage (allchannels)	Regulated current (allchannels)	Similar betweenmiha bodytec II(connection viacable) andprimarypredicatedevice.Similar between
	channels)miha bodytec m.ove:Regulated current (allchannels)			miha bodytec II(connection viai-body connectwireless)/mihabodytec m.oveand secondarypredicatedevice.
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Similar.
AutomaticOverloadTrip?	Yes, no load and shortcircuit conditions arehandled	Yes, no load and shortcircuit conditions arehandled	Yes	Similar.
Automatic No-Load Trip?	Yes, no load and shortcircuit conditions arehandled	Yes, no load and shortcircuit conditions arehandled	Yes	Similar.
AutomaticShut Off?	On/Off-Switch, stimulationstops after defined duration,automatic stop ofstimulation in case of failure/ malfunction detected	On/Off-Switch, stimulationstops after defined duration,automatic stop ofstimulation in case of failure/ malfunction detected	On/Off-Switch	Similar.
PatientOverrideControl?	Yes, while a program isactive the patient issupervised by a trainer andable to manipulate intensity(amplitude) and push thestop button	Yes, while a program isactive the patient issupervised by a trainer andable to manipulate intensity(amplitude) and push thestop button	On/Off-Switch	Similar.
IndicatorDisplay:	Yes	Yes	Yes	Similar.
On/OffStatus?	Yes	Yes	Yes	Similar.
LowBattery?	miha bodytec II (connectionvia cable):N/A, no batterymiha bodytec II (connectionvia i-body connectwireless):Yes, indication of i-bodyconnect wireless batterystatus through mihabodytec II display.miha bodytec m.ove:Yes, indication of mihabodytec m.ove and i-bodyconnect wireless battery	N/A, no battery	Yes	Similar betweenmiha bodytec II(connection viacable) andprimarypredicatedevice.Similar betweenmiha bodytec II(connection viai-body connectwireless) /miha bodytecm.ove and

	status through mihabodytec m.ove display.			secondarypredicatedevice.
- Voltage/CurrentLevel?	Yes, displayed in form ofpercentage / value range	Yes, displayed in form ofpercentage / value range	Yes	Similar.
Timer Range /ProgramDuration(minutes)	Training should not exceed20 minutes; Screen showsremaining time in minutesand displays imageshowing time remaining	Training should not exceed20 minutes; Screen showsremaining time in minutesand displays imageshowing time remaining	Maximum program: 60minutes	No differencebetweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.
Number ofPrograms	11	11	9	Similar
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 andSTART/STOP forimmediate stimulation stop,power-off button, RFIDtransponder cardplacement area.10.1 inch non-touch LCcolor display for program /training plan selection viamenu, settings, devicestatus , training modedisplay (animated avatar,timer, selected program)	Physical buttons and rotaryknobs with pictographs ofthe trained muscles for aquick und usability-orientedsetting of the intensityvalues and multi-functionalbutton for setting, programselection andSTART/STOP forimmediate stimulation stop,power-off button, RFIDtransponder cardplacement area.10.1 inch non-touch LCcolor display for program /training plan selection viamenu, settings, devicestatus , training modedisplay (animated avatar,timer, selected program)	Usage of App withexternal tablet. Touchdisplay.	Similar betweensubject andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.
Portability /Mobile Use	miha bodytec II (connectionvia cable):Portable with difficulty, nomobile device, its intendeduse requires the qualifiedand trained operator.miha bodytec II (connectionvia i-body connectwireless):Portable with difficulty, nomobile device, its intendeduse requires the qualifiedand trained operator.miha bodytec m.ove:Mobile device	Portable with difficulty, nomobile device, its intendeduse requires the qualifiedand trained operator.	Mobile device	Similar betweenmiha bodytec II(connection viacable as wellas connectionvia i-bodyconnectwireless) andprimarypredicatedevice.Similar betweenmiha bodytecm.ove andsecondarypredicatedevice.
Operator	The device must only beoperated by a trainer, who	The device must only beoperated by a trainer, who	N/A	No differencebetweensubject andprimarypredicatedevice.

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	received full training bymiha bodytec.		received full training bymiha bodytec.	primarypredicatedevice
Compliancewith 21 CFR898?(Mandatorysince May 9,2000)	Yes	Yes	Yes	Similar.
Size ofelectrodes	Electrodes with pre-definedsize of 9.75 – 29.14 in²,supplied with the device.Length x Width of electrodepads:3,42 - 30,94 in x 3,15 - 4,37in		Electrodes with pre-definedsize of 9.75 – 64.36 in²,supplied with the device.Length x Width of electrodepads:3,42 - 30,94 in x 3,15 - 4,37in	Electrodes with pre-defined size of 4,31 –83,99 in², supplied withthe device.Differencebetweensubject andprimarypredicatedevice in sizeof biggestelectrode aswell as in areasize of straps.Differencebetweensubject andsecondarypredicate.
Vest size	Size 1andsizeV1 inin²	Size2,size 3andsizev2 inin²	Vest size	Size 1andsizeV1 inin²	Size2,size 3andsizev2 inin²
2electrodesforabdomen	22.85	27.56	2electrodesforabdomen	22.85	27.56
2electrodesfor chest	10.31	12.81	2electrodesfor chest	10.31	12.81
2electrodesfor upperback	16.25	20.98	2electrodesfor upperback	16.25	20.98
2electrodesfor sides ofback	9.75	11.85	2electrodesfor sides ofback	9.75	11.85
2electrodesfor lowerback	14.4	19.47	2electrodesfor lowerback	14.4	19.47
Strap size	Electrode sizein²		Strap size	Electrode sizein²
Size 1(pair)	Each 16.74		Size 1(pair)	Each 34.15
Size 2(pair)	Each 20.77		Size 2(pair)	Each 48.77
Size 3(pair)	Each 29.14		Size 3(pair)	Each 64.36
belt size	Electrode sizein²		belt size	Electrode sizein²
Size 1(pair)	Each 14.7		Size 1(pair)	Each 14.7
Size 2(pair)	Each 18.34		Size 2(pair)	Each 18.34

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Plugs	miha bodytec II (connectionvia cable):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.miha bodytec II (connectionvia i-body connectwireless):Either main cable with D-Sub 25 pin connector to thecontrol unit and proprietarymagnetic connector to the i-body vest or the i-bodyconnect wireless connectsto the i-body vest with amagnetic pogo pinconnector. Cables betweenvest and strap / belt withproprietary connectors.miha bodytec m.ove:the i-body connect wirelessconnects to the i-body vestwith a magnetic pogo pinconnector. Cables betweenvest and strap / belt withproprietary connectors.	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.	The Impulse Packconnects to the Suitthrough output cablesthat terminate withmagnetic pogo pinconnectors.The Suit also featuresleads with snapconnectors forconnecting to the armelectrodes	No differencebetween mihabodytec II(connection viacable) andprimarypredicatedevice.Differencebetweensubject deviceand secondarypredicatedevice.
Lead wires - cables	miha bodytec II (connectionvia cable):1. Main cable with D-Sub 25pin connector to the controlunit and proprietarymagnetic connector to the i-body vest. Length: 3000mm, Polyurethane jacket.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 vest;Polyurethane jacketCompliant with protectedlead wire and patient cablesafety requirementsmiha bodytec II (connectionvia i-body connectwireless):1. Main cable with D-Sub 25pin connector to the controlunit and proprietarymagnetic connector to the i-	1. Main cable with D-Sub 25pin connector to the controlunit and proprietarymagnetic connector to the i-body vest. Length: 3000mm, Polyurethane jacket.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 vest;Polyurethane jacketCompliant with protectedlead wire and patient cablesafety requirements	1. The Impulse Packconnects to the Suitthrough outputcables that terminatewith pogo pinconnectors.2. The Suit featuresleadswith snap connectors forconnecting to the armelectrodes3. The Suit contains anembedded cableharness which makesconnection with thebuilt-in electrodes.Neither the cableharness or theelectrodes areremovable.	Similar
	body vest. Length: 3000mm, Polyurethane jacket.1.1 in i-body connectwireless firmly mountedcable with magneticconnector to the i-body

	vest. Length: 900 mm,Polyurethane jacket.
	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 vest;Polyurethane jacket
	Compliant with protectedlead wire and patient cablesafety requirements
	miha bodytec m.ove:1.1 in i-body connectwireless firmly mountedcable with magneticconnector to the i-bodyvest. Length: 900 mm,Polyurethane jacket.
	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 vest;Polyurethane jacket
	Compliant with protectedlead wire and patient cablesafety requirements
Conductivityof theelectrodes	The athlete needs to put onthe genuine andbiocompatible miha bodytecundergarments (pants andshirt) under the i-bodyaccessories (vest, strapand belt).	The athlete needs to put onthe genuine andbiocompatible miha bodytecundergarments (pants andshirt) under the i-bodyaccessories (vest, strapand belt).	The base layer isdesigned to be wornunderneath the suitduring training andshould have directcontact with your skin. Itconsists of a shirt and apair of shorts.	Similar.
	The absorbent electrodescovers on the i-body vest,strap and belt need to bemoistened using a pumpspray bottle with tap water.	The absorbent electrodescovers on the i-body vest,strap and belt need to bemoistened using a pumpspray bottle with tap water.	Electrode pads of thesuit must be wetted witha spray bottle to get thebest connectivity for theworkouts.
	The electrode vest, strapsand belt are washable.	The electrode vest, strapsand belt are washable.	The suit is washable.
Placement ofthe electrodes	Appropriately pre-placedin specific areas accordingto muscle anatomy.Electrodes are firmlymounted into the vest, beltor straps. The electrodes	Appropriately pre-placedin specific areas accordingto muscle anatomy.Electrodes are firmlymounted into the vest, beltor straps. The electrodes	The electrodes arepreplaced and firmlymounted into the suit.They are not removable.	Similar.
	itself cannot be separatedfrom the textile and cannotbe exchanged.	itself cannot be separatedfrom the textile and cannotbe exchanged.
Material ofelectrodes	The conductive electrodeitself (under the textile) ismade out of a 100%BEKINOX Stainless Steel	The conductive electrodeitself (under the textile) ismade out of a 100%BEKINOX Stainless Steel	No direct skin contact.Further information notpublicly available.	Similar
	No direct skin contact possible.	No direct skin contact possible.
Maximumduration foruse pertreatment	Max. 20 minutes pertreatment.	Max. 20 minutes pertreatment.	Max. 60 minutes.	No differencebetween subjectand primarypredicatedevice.Differencebetween subjectand secondarypredicatedevice.
Accessories	i-body connect wirelessi-body vesti-body strapi-body beltUndergarmentsTransponder card	i-body vesti-body strapi-body beltUndergarmentsTransponder card	Impulse packSuit (consists of vest,shorts, arm straps, armconnectors)Base layer	Similar.
Weight	miha bodytec II (connectionvia cable):Complete: 45.2 lbControl unit: 10.3 lbi-body® with cable set: 3.3lbi-body® belt: 0.9 lbi-body® strap: 0.44 lbmiha bodytec II (connectionvia i-body connectwireless):Complete: 45.2 lbControl unit: 10.3 lbi-body connect wireless: 1.3lbi-body® with cable set: 3.3lbi-body® belt: 0.9 lbi-body® strap: 0.44 lbmiha bodytec m.ove:Control unit: 7.5 lbi-body connect wireless: 1.3lbi-body® with cable set: 3.3lbi-body® belt: 0.9 lbi-body® strap: 0.44 lbwork station m.ove withmaximum load: max. 110 lbtravel station m.ove withmaximum load: max. 55 lb	Complete: 45.2 lbControl unit: 10.3 lbi-body® with cable set: 3.3lbi-body® belt: 0.9 lbi-body® strap: 0.55 lb	Impulse Pack - 248 g(0,55 lb)	Similar betweenmiha bodytec II(connection viacable) andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.

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Dimensions(ft.) [W x H xD]	miha bodytec II (connectionvia cable):Control unit: 1.39 x 0.89 x0.23 (W x D x H in ft)Complete: 1.77 x 1.69 x3.89 (W x D x H in ft)miha bodytec II (connectionvia i-body connectwireless):Control unit: 1.39 x 0.89 x0.23 (W x D x H in ft)Complete: 1.77 x 1.69 x3.89 (W x D x H in ft)i-body connect wireless:0.29 x 0.38 x 0.18 (W x D xH in ft)miha bodytec m.ove:Control unit: 1.39 x 0.95 x0.23 (W x D x H in ft)i-body connect wireless:0.29 x 0.38 x 0.18 (W x D xH in ft)work station m.ove: 1.83 x3.12 x 3.74 (W x D x H inft)	Control unit: 1.39 x 0.89 x0.23 (W x D x H in ft)Complete: 1.77 x 1.69 x3.89 (W x D x H in ft)	Impulse Pack– 148x78 mm (0,49x0,26ft)Connector 1– 65x32mm (0,21x0,10ft)Connector 2– 56x32mm (0,18x0,10)	No differencebetween mihabodytec II(connection viacable) andprimarypredicatedevice.Differencebetweensubject andsecondarypredicatedevice.
	travel station m.ove: 1.60 x0.98 x 3.15 (W x D x H inft)
HousingMaterials andConstruction	miha bodytec II (connectionvia cable):Control unit: Aluminummiha bodytec II (connectionvia i-body connectwireless):Control unit: Aluminumi-body connect wireless:Plastic injection moldingmiha bodytec m.ove:Control unit: Plastic injectionmoldingi-body connect wireless:Plastic injection molding	Control unit:Aluminum	Plastic injection molding	No differencebetween mihabodytec II(connection viacable) andprimarypredicatedevice.Similar betweenmiha bodytec II(connection viai-body connectwireless) andprimarypredicatedevice.Similar betweenmiha bodytecm.ove andsecondarypredicatedevice.
Standards	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 AndA1:2012IEC 60601-1-2:2014	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 AndA1:2012IEC 60601-1-2:2014	ISO 14971:2007AAMI ANSI ES 60601-1_2005/(R)2012 AndA1:2012IEC 60601-1IEC 60601-1-2	Similar.

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IEC 60601-2-10:2012	IEC 60601-2-10:2012	IEC 60601-2-10
IEC 62304:2015	IEC 62304:2015	IEC 62304:2015
ISO 10993-5:2009	ISO 10993-5:2009	ISO 10993-5:2009
ISO 10993-10:2010	ISO 10993-10:2010	ISO 10993-10:2010
		IEC 62133:2012

Table 1: Basic Device Characteristics – Comparison with Predicate Device

Output Specifications

Characteristic New Device		Primary PredicateDevice	Secondary PredicateDevice	Similar / Different
Waveform	Symmetric biphasic	Symmetric biphasic	Symmetric biphasic	Similar.
Shape	Rectangular	Rectangular	Rectangular	Similar.
MaximumOutputVoltage	miha bodytec II(connection via cable):<= 74Vp @ 500Ω (54 - 74Vp)<= 152Vp @ 2kΩ (110 ...152 Vp)<= 152Vp @ 10kΩ (130 ...152 Vp)miha bodytec II(connection via i-bodyconnect wireless):<= 76,2Vp @ 500 Ω (74,32– 76,2Vp)<= 111Vp @ 2 kΩ (107,36– 111Vp)<= 117Vp @ 10 kΩ (101,5– 117Vp)miha bodytec m.ove:<= 76,2Vp @ 500 Ω (74,32- 76,2Vp)<= 111Vp @ 2 kΩ (107,36- 111Vp)<= 117Vp @ 10 kΩ (101,5- 117Vp)	<= 74Vp @ 500Ω (54 - 74Vp)<= 152Vp @ 2kΩ (110 ...152 Vp)<= 152Vp @ 10kΩ (130 ...152 Vp)	60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ	No differencebetween mihabodytec II(connection viacable) and primarypredicate device.Difference betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andprimary predicatedevice as well asbetween all subjectdevices andsecondarypredicate device.
MaximumOutputCurrent	miha bodytec II(connection via cable):< 148mAp @ 500Ω (108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ (13-15mAp)miha bodytec II(connection via i-bodyconnect wireless):< 152,4mAp @ 500 Ω(148,63 - 152,4mAp)< 55,5mAp @ 2 kΩ (53,68- 55,5mAp)	< 148mAp @ 500Ω (108-148mAp)< 76mAp @ 2kΩ (55-76mAp)< 15 mAp @ 10kΩ (13-15mAp)	120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩ	No differencebetween mihabodytec II(connection viacable) and primarypredicate device.Difference betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andprimary predicatedevice as well asbetween all subjectdevices and
	< 11,7mAp @ 10 kΩ(10,15 - 11,7mAp)miha bodytec m.ove:< 152,4mAp @ 500 Ω(148,63 - 152,4mAp)< 55,5mAp @ 2 kΩ (53,68- 55,5mAp)< 11,7mAp @ 10 kΩ(10,15 - 11,7mAp)			secondarypredicate device.
Pulse Width	50 - 400 µs	50 - 400 µs	250 - 375 µs	No differencebetween subjectdevice and primarypredicate device.Similar betweensubject device andsecondarypredicate device interms of maximumpulse width.Difference betweensubject device andsecondarypredicate device interms of minimumpulse width.
Frequency(Hz)	miha bodytec II(connection via cable):2 - 150 Hzmiha bodytec II(connection via i-bodyconnect wireless):2 - 100 Hzmiha bodytec m.ove:2 - 100 Hz	2 - 150 Hz	1 - 105 Hz	No differencebetween mihabodytec II(connection viacable) and primarypredicate device.Similar betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andsecondarypredicate device
Symmetricalphases?	Yes	Yes	Yes	Similar.
PhaseDuration	25 ... 200 µs	25 ... 200 µs	250 ... 375 µs	No differencebetween subjectdevice and primarypredicate device.Difference betweensubject device andsecondarypredicate device.
MaximumPhaseCharge	miha bodytec II(connection via cable):<32 µC @ 500Ωmiha bodytec II(connection via i-bodyconnect wireless):	<32 µC @ 500Ω	45 µC @ 500Ω	No differencebetween mihabodytec II(connection via
	< 30,48 μC @ 500Ωmiha bodytec m.ove:< 30,48 μC @ 500Ω			cable) and primarypredicate device.
				Difference betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andprimary predicatedevice as well asbetween all subjectdevices andsecondarypredicate device.
MaximumCurrentDensity	miha bodytec II(connection via cable):0.64 mA/cm² @ 500Ωmiha bodytec II(connection via i-bodyconnect wireless):0,42 mA/cm² @ 500 Ωmiha bodytec m.ove:0,42 mA/cm² @ 500 Ω	0.64 mA/cm² @ 500Ω	1.15 mA/cm² @ 500Ω	No differencebetween mihabodytec II(connection viacable) and primarypredicate device.Difference betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andprimary predicatedevice as well asbetween all subjectdevices andsecondarypredicate device.
MaximumPowerDensity	miha bodytec II(connection via cable):0.82 mW/cm² @ 500Ωmiha bodytec II(connection via i-bodyconnect wireless):5,47 mW/cm² @ 500 Ωmiha bodytec m.ove:5,47 mW/cm² @ 500 Ω	0.82 mW/cm² @ 500Ω	22.68 mW/cm² @ 500Ω	No differencebetween mihabodytec II(connection viacable) and primarypredicate device.Difference betweenmiha bodytec II(connection via i-body connectwireless), mihabodytec m.ove andprimary predicatedevice as well asbetween all subjectdevices andsecondarypredicate device.
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 differencebetween subjectand primarypredicate device.
Safety circuits			N.A.	Similar between
	miha bodytec II(connection via cable):Short-circuit monitoring,watchdog monitoring, noload trip, onload trip,button for immediate shutoff, redundant hardwareerror monitoring(emergency STOP option)Firmware self-tests.	Short-circuit monitoring,watchdog monitoring, noload trip, onload trip,button for immediate shutoff, redundant hardwareerror monitoring(emergency STOP option)Firmware self-tests.		subject devices and
	miha bodytec II(connection via i-bodyconnect wireless):Overcurrent monitoring,channel monitoring,watchdog monitoring,button for immediate shutoff, redundant hardwareerror monitoring(emergency STOP option)Firmware self-tests,firmware no loaddetection			primary predicatedevice.
	miha bodytec m.ove:Overcurrent monitoring,channel monitoring,watchdog monitoring,button for immediate shutoff, redundant hardwareerror monitoring(emergency STOP option)Firmware self-tests,firmware no loaddetection

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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. 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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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 lateral back-electrodes, 1 upper back-electrode and 1 abdomen-electrode were selected. The electrodes were cut out of the vest and moistened to be covered by the undergarments. 8 measure points from each chest-electrode, each lateral back-electrode and each upper back-electrode as well as 5 measure points from each abdomenelectrode 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 10 weeks. Through testing the electrical resistance of the electrodes, a 3-year storage was tested. Altogether 10 electrodes and 6 contact points were tested. All tests were 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 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62304:2006 + A1:2015 - Medical Device Software - Software Life Cycle Processes
. ISO 14971:2007 - Medical Devices - Application Of Risk Management To Medical Devices
IEC 62366-1:2015 + COR1:2016 - Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
. 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
ANSI IEEE C63.27-2017 - American National Standard for Evaluation of Wireless Coexistence

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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
. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Document issued on: September 4, 2020
. Radio Frequency Wireless Technology in Medical Devices, Issued August 13, 2013, Document issued on: August 14, 2013
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered ● Medical Devices, Document issued on: July 11, 2016.

Conclusion

None of the differences identified raise any new issues regarding safety or effectiveness. Therefore, we conclude that miha bodytec II (3ºº generation) is substantially equivalent to the primary predicate device miha bodytec II (2nd generation) as well as the secondary predicate device Katalyst Training System.

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).