Miha Bodytec II

K221498 · Miha Bodytec GmbH · NGX · Oct 7, 2022 · Physical Medicine

Device Facts

• Record ID: K221498
• Device Name: Miha Bodytec II
• Applicant: Miha Bodytec GmbH
• Product Code: NGX · Physical Medicine
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Transcutaneous electrical muscle stimulation (EMS) device; stimulates motor nerves via electrodes to induce muscle contraction. Inputs: user-selected training programs (impulse familiarization, endurance, relaxation) and intensity settings. Operation: control unit (stationary or mobile) transmits electrical signals to electrodes via cable or wireless 'i-body connect wireless' module. Electrodes integrated into vest, straps, and belt. Used in professional settings (clinics, hospitals, sports facilities) by trained operators. Trainer selects programs, adjusts intensity per channel, and monitors patient. Output: symmetric biphasic electrical pulses. Benefits: muscle performance improvement, spasm relaxation, atrophy prevention. Wireless variant enables remote control of stimulation via Bluetooth-linked module.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software validation (IEC 62304), usability validation, and electrode dispersion/shelf-life testing (ASTM F1980-16). Oscilloscope tracings verified output waveforms under various loads.

Technological Characteristics

Transcutaneous EMS; symmetric biphasic rectangular pulses. Materials: BEKINOX stainless steel electrodes, aluminum/plastic housing. Connectivity: Wired or Bluetooth (wireless module). Power: External supply or Li-Ion battery. Standards: IEC 60601-1, IEC 60601-2-10, ISO 10993, ISO 14971. Software: Firmware-controlled, channel-selective stimulation.

Indications for Use

Indicated for adults over 21 for muscle re-education, relaxation of muscle spasms, and retarding/preventing disuse muscle atrophy. Used as an adjunct to sports and for muscle training. Contraindicated for use on injured or ailing muscles.

Regulatory Classification

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.

Predicate Devices

• miha bodytec II (K201975)
• Katalyst Training System (K190966)

Submission Summary (Full Text)

{0}------------------------------------------------

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

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

### 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

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.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 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<br>Siemensstr. 1<br>86368 Gersthofen<br>Germany |
|-----------------|-------------------------------------------------------------------|
| Contact Person: | Felix Schweigert<br>[e-mail]<br>[phone] - 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

{4}------------------------------------------------

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 and Function

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

{5}------------------------------------------------

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.

| 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

{6}------------------------------------------------

| Indications for Use | | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| miha bodytec II (MBT II) is a<br>machine with electronic<br>muscle stimulation based<br>on EMS technology.<br>Regarding its use, the<br>device is specifically<br>designed as an addition to<br>other sports and for training<br>muscles.<br>miha bodytec II is intended<br>to stimulate muscles in<br>order to improve or facilitate<br>muscle performance. In<br>addition it is indicated for<br>the following conditions:<br>- Re-educating muscles<br>- Relaxation of muscle<br>spasm<br>- Retarding or preventing<br>disuse muscle atrophy<br>The miha bodytec II<br>electrical impulses allow the<br>triggering of action<br>potentials on motoneurons<br>of motor nerves<br>(excitations). These<br>excitations of motoneurons<br>are transmitted to the<br>muscle fibers via the motor<br>endplate where they<br>generate mechanical<br>muscle fiber responses that<br>correspond to muscle work.<br>Depending on the<br>parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration), different<br>types of muscle work can<br>be imposed on the<br>stimulated muscles. | miha bodytec II (MBT II) is a<br>machine with electronic<br>muscle stimulation based<br>on EMS technology.<br>Regarding its use, the<br>device is specifically<br>designed as an addition to<br>other sports and for training<br>muscles.<br>miha bodytec II is intended<br>to stimulate muscles in<br>order to improve or facilitate<br>muscle performance. In<br>addition it is indicated for<br>the following conditions:<br>- Re-educating muscles<br>- Relaxation of muscle<br>spasm<br>- Retarding or preventing<br>disuse muscle atrophy<br>The miha bodytec II<br>electrical impulses allow the<br>triggering of action<br>potentials on motoneurons<br>of motor nerves<br>(excitations). These<br>excitations ofmotoneurons<br>are transmitted to the<br>muscle fibers via the motor<br>endplate where they<br>generate mechanical<br>muscle fiber responses that<br>correspond to muscle work.<br>Depending on the<br>parameters of the electrical<br>impulses (pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration), different<br>types of muscle work can<br>be imposed on the<br>stimulated muscles. | The Katalyst Training<br>System is an Over-The-<br>Counter device intended<br>to stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle performance. It<br>is to be used by adults<br>only.<br>The Katalyst Training<br>System is not intended<br>to be used in<br>conjunction with therapy<br>or treatment of medical<br>diseases or medical<br>conditions of any kind.<br>None of the training<br>programs or operational<br>parameters are<br>designed to target<br>injured or ailing muscles<br>and its use on such<br>muscles is<br>contraindicated. The<br>Katalyst Training<br>System's electrical<br>impulses allow the<br>triggering of action<br>potentials on<br>motoneurons of motor<br>nerves (excitations).<br>These excitations of<br>motoneurons are<br>transmitted to the<br>muscle fibers via the<br>motor endplate where<br>they generate<br>mechanical muscle fiber<br>responses that<br>correspond to muscle<br>work. Depending on the<br>parameters of the<br>electrical impulses<br>(pulse frequency,<br>duration of contraction,<br>duration of rest, total<br>session duration),<br>different types of muscle<br>work can be imposed on<br>the stimulated muscles. | Similar between<br>subject and<br>primary<br>predicate<br>device.<br>Similar between<br>subject and<br>secondary<br>predicate<br>device in terms<br>of indications<br>for use related<br>to the product<br>code NGX. The<br>secondary<br>predicate<br>device does<br>not have listed<br>the IPF related<br>muscle<br>conditioning<br>indications. | | | | |
| Connection of<br>the device to<br>electrodes | | | | | | | |
| miha bodytec II (connection<br>via cable): One stimulation<br>module / control unit which<br>is channel-wise connected<br>to the i-body® electrodes<br>over a cable to the i-body®<br>vest. The electrodes of the<br>i-body® straps and belt are<br>connected via cables to the<br>vest.<br><br>miha bodytec II (connection<br>via i-body connect<br>wireless):<br>The body worn i-body | via i-body connect<br>wireless):<br>The body worn i-body<br>connect wireless is | One stimulation module /<br>control unit which is<br>channel-wise connected to<br>the i-body® electrodes over<br>a cable to the i-body® vest.<br>The electrodes of the i-<br>body® straps and belt are<br>connected via cables to the<br>vest. | | The Impulse Pack<br>connects to the Suit<br>through output cables<br>that terminate with pogo<br>pin connectors. The Suit<br>contains an embedded<br>cable harness which<br>makes connection with<br>the built-in electrodes.<br>Neither the cable<br>harness or the<br>electrodes are<br>removable. The Suit<br>also features leads with | electrodes are<br>removable. The Suit<br>also features leads with<br>snap connectors for | Similar between<br>miha bodytec II<br>(connection via<br>cable) and<br>primary<br>predicate<br>device.<br><br>Similar between<br>miha bodytec II<br>(connection via<br>i-body connect<br>wireless)/miha<br>bodytec m.ove | i-body connect<br>wireless)/miha<br>bodytec m.ove<br>and secondary |

{7}------------------------------------------------

| | controlled by the miha<br>bodytec II via Bluetooth and<br>connects to the i-body vest<br>through a short cable. The<br>electrodes of the i-body®<br>straps and belt are<br>connected via cables to the<br>vest.<br>miha bodytec m.ove:<br>The body worn i-body<br>connect wireless is<br>controlled by the miha<br>bodytec m.ove via<br>Bluetooth and connects to<br>the i-body vest through a<br>short cable. The electrodes<br>of the i-body® straps and<br>belt are connected via<br>cables to the vest. | connecting to the arm<br>electrodes | predicate<br>device. | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power<br>Source(s) | miha bodytec II:<br>Control unit: 15 V – 19 V;<br>External power supply (100<br>– 240 V ~ 50 – 60 Hz)<br>miha bodytec m.ove:<br>Lithium Ion (Li-Ion)<br>rechargeable battery<br>14.4V, 6900 mAh; Usage via<br>external power supply<br>possible as well (100 – 240<br>V ~ 50 – 60 Hz)<br>i-body connect wireless:<br>Lithium Ion (Li-Ion)<br>rechargeable battery<br>7.2V, 2900 mAh | Lithium Polymer (Li-Po)<br>rechargeable battery<br>7.4V, 2,050 mAh | No difference<br>between miha<br>bodytec II and<br>primay<br>predicate<br>device.<br>Difference<br>between<br>batteries of<br>miha bodytec<br>m.ove/i-body<br>conncect<br>wireless and<br>secondary<br>predicate<br>device due to<br>higher power. | |
| - Method of<br>Line Current<br>Isolation | miha bodytec II:<br>Power Supply in accordance<br>with IEC 60601-1<br>miha bodytec m.ove:<br>N/A (battery operated<br>device);<br>Usage with power supply:<br>Power Supply in<br>accordance with IEC<br>60601-1<br>i-body connect wireless:<br>N/A (battery operated<br>device) | N/A (battery operated<br>device) | Similar between<br>miha bodytec II<br>and primary<br>predicate<br>device.<br>Similar between<br>miha bodytec<br>m.ove/i-body<br>connect<br>wireless and<br>secondary<br>predicate<br>device. | |
| - Patient<br>Leakage<br>Current | miha bodytec II:<br>< 100 μA<br>miha bodytec m.ove:<br>N/A (battery operated<br>device);<br>Usage with power supply:<br>< 100 μA<br>i-body connect wireless:<br>N/A (battery operated<br>device) | < 100 μA | Similar between<br>miha bodytec II<br>and primary<br>predicate<br>device.<br>Similar between<br>miha bodytec<br>m.ove/i-<br>body connect<br>wireless and | |
| | | | | secondary<br>predicate<br>device. |
| - Normal<br>condition | miha bodytec II:<br>< 100 μA<br>miha bodytec m.ove:<br>N/A (battery operated<br>device);<br>Usage with power supply:<br>< 100 μA<br>i-body connect wireless:<br>N/A (battery operated<br>device) | < 100 μA | N/A (battery operated<br>device) | Similar between<br>miha bodytec II<br>and primary<br>predicate<br>device.<br>Similar between<br>miha bodytec<br>m.ove/i-body<br>connect<br>wireless and<br>secondary<br>predicate<br>device. |
| - Single<br>fault<br>condition | miha bodytec II:<br>< 100 μA<br>miha bodytec m.ove:<br>N/A (battery operated<br>device);<br>Usage with power supply:<br>< 100 μA<br>i-body connect wireless:<br>N/A (battery operated<br>device) | < 100 μA | N/A (battery operated<br>device) | Similar between<br>miha bodytec II<br>and primary<br>predicate<br>device.<br>Similar between<br>miha bodytec<br>m.ove/i-body<br>connect<br>wireless and<br>secondary<br>predicate<br>device. |
| - Number of<br>Output<br>Modes | One (symmetric biphasic)<br>with 6 training programs | One (symmetric biphasic)<br>with 6 training programs | One (NMES) | Similar. |
| - Number of<br>Output<br>Channels | miha bodytec II (connection<br>via cable):<br>10, channel selective<br>stimulation.<br>Maximum one channel is<br>active at any time.<br>miha bodytec II (connection<br>via i-body connect<br>wireless):<br>8, Maximum one channel is<br>active at any time.<br>miha bodytec m.ove:<br>8, Maximum one channel is<br>active at any time. | 10, channel selective<br>stimulation.<br>Maximum one channel is<br>active at any time. | 13 | No difference<br>between miha<br>bodytec II<br>(connection via<br>cable) with<br>primary<br>predicate<br>device.<br>Difference of all<br>variants in<br>comparison<br>with secondary<br>predicate<br>device. |
| - Synchronous<br>or<br>Alternating? | Alternating | Alternating | Synchronous, but never<br>2 channels activated at<br>the same time | Similar |
| - Method of<br>Channel<br>Isolation | Multiplexed by control unit | Multiplexed by control unit | Multi-Channel High<br>Voltage Analog<br>Switches. Except during<br>channel activation, each | Similar. |
| | | | channel is always in<br>high Z state | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | miha bodytec II (connection<br>via cable):<br>Regulated voltage (all<br>channels)<br>miha bodytec II (connection<br>via i-body connect<br>wireless):<br>Regulated current (all | Regulated voltage (all<br>channels) | Regulated current (all<br>channels) | Similar between<br>miha bodytec II<br>(connection via<br>cable) and<br>primary<br>predicate<br>device.<br>Similar between |
| | channels)<br>miha bodytec m.ove:<br>Regulated current (all<br>channels) | | | miha bodytec II<br>(connection via<br>i-body connect<br>wireless)/miha<br>bodytec m.ove<br>and secondary<br>predicate<br>device. |
| Software/<br>Firmware/<br>Microprocess<br>or Control? | Yes | Yes | Yes | Similar. |
| Automatic<br>Overload<br>Trip? | Yes, no load and short<br>circuit conditions are<br>handled | Yes, no load and short<br>circuit conditions are<br>handled | Yes | Similar. |
| Automatic No-<br>Load Trip? | Yes, no load and short<br>circuit conditions are<br>handled | Yes, no load and short<br>circuit conditions are<br>handled | Yes | Similar. |
| Automatic<br>Shut Off? | On/Off-Switch, stimulation<br>stops after defined duration,<br>automatic stop of<br>stimulation in case of failure<br>/ malfunction detected | On/Off-Switch, stimulation<br>stops after defined duration,<br>automatic stop of<br>stimulation in case of failure<br>/ malfunction detected | On/Off-Switch | Similar. |
| Patient<br>Override<br>Control? | Yes, while a program is<br>active the patient is<br>supervised by a trainer and<br>able to manipulate intensity<br>(amplitude) and push the<br>stop button | Yes, while a program is<br>active the patient is<br>supervised by a trainer and<br>able to manipulate intensity<br>(amplitude) and push the<br>stop button | On/Off-Switch | Similar. |
| Indicator<br>Display: | Yes | Yes | Yes | Similar. |
| On/Off<br>Status? | Yes | Yes | Yes | Similar. |
| Low<br>Battery? | miha bodytec II (connection<br>via cable):<br>N/A, no battery<br>miha bodytec II (connection<br>via i-body connect<br>wireless):<br>Yes, indication of i-body<br>connect wireless battery<br>status through miha<br>bodytec II display.<br>miha bodytec m.ove:<br>Yes, indication of miha<br>bodytec m.ove and i-body<br>connect wireless battery | N/A, no battery | Yes | Similar between<br>miha bodytec II<br>(connection via<br>cable) and<br>primary<br>predicate<br>device.<br>Similar between<br>miha bodytec II<br>(connection via<br>i-body connect<br>wireless) /<br>miha bodytec<br>m.ove and |
| | | | | |
| | status through miha<br>bodytec m.ove display. | | | secondary<br>predicate<br>device. |
| - Voltage/<br>Current<br>Level? | Yes, displayed in form of<br>percentage / value range…