miha bodytec II

K201975 · Miha Bodytec GmbH · NGX · Mar 11, 2021 · Physical Medicine

Device Facts

• Record ID: K201975
• Device Name: miha bodytec II
• Applicant: Miha Bodytec GmbH
• Product Code: NGX · Physical Medicine
• Decision Date: Mar 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

miha bodytec II (MBT II) is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions: - Re-educating muscles - Relaxation of muscle spasm - Retarding or preventing disuse muscle atrophy

Device Story

Transcutaneous electrical muscle stimulation (EMS) device; stimulates motor nerves via electrical impulses to generate mechanical muscle fiber responses. Inputs: user-selected training programs (impulse familiarization, invigoration, endurance, relaxation) and intensity settings. Outputs: symmetric biphasic electrical pulses delivered to up to 10 electrode pairs via i-body vest, straps, and belt. Used in professional settings (clinics, hospitals, sports facilities) by trained operators. Trainer applies electrodes over undergarments, selects programs, and adjusts intensity per channel. Athlete/patient performs specific exercises during stimulation. Benefits: muscle performance improvement, muscle re-education, spasm relaxation, and atrophy prevention. RFID transponder stores individual training data.

Clinical Evidence

Bench testing only. Includes electrical safety/EMC testing, software/firmware validation (IEC 62304), usability validation, electrode dispersion testing, and accelerated aging (ASTM F1980-16) for shelf-life verification. No clinical data presented.

Technological Characteristics

Powered muscle stimulator; symmetric biphasic waveform. Materials: BEKINOX stainless steel multifilament yarn electrodes, aluminum control unit housing. Energy: 15-19V external power supply. Connectivity: wired (D-Sub 25-pin, proprietary magnetic connectors). Dimensions: 1.39x0.89x0.23 ft (control unit). Software: firmware-based, IEC 62304 compliant. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 14971, ISO 10993.

Indications for Use

Indicated for healthy individuals to improve or facilitate muscle performance, re-educate muscles, relax muscle spasms, and retard or prevent disuse muscle atrophy. 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 (K182519)
• Compex rehab (K090632)

Submission Summary (Full Text)

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March 11, 2021

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

Re: K201975

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

Dear Felix Schweigert:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

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

Enclosure

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#### Indications for Use

510(k) Number (if known) K201975

Device Name miha bodytec II

#### Indications for Use (Describe)

miha bodytec II (MBT II) is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles.

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

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

The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary for miha bodytec II

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

### Sponsor

- Sponsor: miha bodytec GmbH Siemensstr. 1 86368 Gersthofen Germany
- Contact Person: Felix Schweigert [e-mail] Germany: [phone] - 22 US: [phone]
- Date Prepared: July 06, 2020
- 510(k) number: K201975

### Device Name and Classification

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

### Predicate Device

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

### Intended Use

miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles.

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

- Re-educating muscles

- Relaxation of muscle spasm

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- Retarding or preventing disuse muscle atrophy
The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

# Device Description and Function

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

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

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

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

# Predicate Device Comparison

| Characteristic | New Device | Primary predicate<br>device | Secondary<br>Predicate Device | Similar /<br>Different |
|------------------|------------|-----------------------------|-------------------------------|------------------------|
| 510(k)<br>Number | K201975 | K182519 | K090632 | - |

General

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| Device Name,<br>Model | miha bodytec II | miha bodytec II | Compex rehab | - |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | miha bodytec GmbH | miha bodytec GmbH | Chattanoogah | - |
| Regulation<br>Number | 890.5850 | 890.5850 | 890.5850 | Similar. |
| Product code | NGX; IPF | NGX | IPF | Different.<br>The subject<br>device<br>combines<br>both<br>product<br>codes NGX<br>and IPF of<br>the<br>predicate<br>devices<br>within the<br>same<br>regulation<br>number. |
| Indications for<br>Use | miha bodytec II is a<br>machine with electronic<br>muscle stimulation<br>based on EMS<br>technology. Regarding<br>its use, the device is<br>specifically designed as<br>an addition to other<br>sports and for training<br>muscles. | miha bodytec II is a<br>machine with electronic<br>muscle stimulation<br>based on EMS<br>technology. Regarding<br>its use, the device is<br>specifically designed as<br>an addition to other<br>sports and for training<br>muscles. It must be<br>used for healthy<br>muscles and clients, not<br>be used for<br>rehabilitation purposes. | The Compex®<br>Rehab is an<br>adjunctive<br>multifunction<br>electrotherapy<br>device with various<br>treatment modes<br>that allow for<br>neuromuscular<br>electrical<br>stimulation<br>(NMES). The<br>Compex® Rehab is<br>indicated for the<br>following<br>conditions: | Similar<br>between<br>subject and<br>primary<br>predicate<br>device in<br>terms of<br>indications<br>for use<br>NGX.<br>The<br>primary<br>predicate<br>device does<br>not cover<br>the IPF<br>related |
| | miha bodytec II is<br>intended to stimulate<br>muscles in order to<br>improve or facilitate<br>muscle performance. In<br>Addition it is indicated<br>for the following<br>conditions:<br>- Re-educating muscles | miha bodytec II is<br>intended to stimulate<br>healthy muscles in<br>order to improve or<br>facilitate muscle<br>performance. miha<br>bodytec II is not<br>intended to be used in<br>conjunction with | - Re-educating<br>muscles | therapeutic<br>indications.<br>Similar<br>between<br>subject and<br>secondary<br>predicate<br>device in<br>terms of |
| | - Relaxation of muscle<br>spasm | therapy or treatment of<br>medical diseases or | - Relaxation of<br>muscle spasm | indications<br>for use IPF. |
| - Retarding or | medical conditions of | - Increasing local | The | |
| preventing disuse | any kind. None of the | blood circulation | secondary | |
| muscle atrophy | miha bodytec II training | - Retarding or | predicate | |
| The miha bodytec II | programs are designed | preventing disuse | device does | |
| electrical impulses allow | for injured or ailing | atrophy | not cover | |
| the triggering of action | muscles and its use on | - Maintaining or | the NGX | |
| potentials on | such muscles is | increasing range of | related | |
| motoneurons of motor | contraindicated. | motion | muscle | |
| nerves (excitations). | The miha bodytec II | | conditionin | |
| These excitations of | electrical impulses allow | | g | |
| motoneurons are | the triggering of action | | indications. | |
| transmitted to the | potentials on | | | |
| muscle fibers via the | motoneurons of motor | | However, | |
| motor endplate where | nerves (excitations). | | despite the | |
| they generate | These excitations of | | differences | |
| mechanical muscle fiber | motoneurons are | | in | |
| responses that | transmitted to the | | indications, | |
| correspond to muscle | muscle fibers via the | | the general | |
| work. Depending on the | motor endplate where | | intended | |
| parameters of the | they generate | | use, | |
| electrical impulses | mechanical muscle fiber | | powered | |
| (pulse frequency, | responses that | | muscle | |
| duration of contraction, | correspond to muscle | | stimulator | |
| duration of rest, total | work. Depending on the | | for medical | |
| session duration), | parameters of the | | purposes, | |
| different types of | electrical impulses | | is the | |
| muscle work can be | (pulse frequency, | | same. | |
| imposed on the | duration of contraction, | | Moreover, | |
| stimulated muscles. | duration of rest, total | | the subject | |
| | session duration), | | device | |
| | different types of | | combines | |
| | muscle work can be | | both | |
| | imposed on the | | indications | |
| | stimulated muscles. | | and does | |
| | The various types of | | not add | |
| | muscle work that the | | additional | |
| | miha bodytec II can | | indications. | |
| | impose on the | | | |
| | stimulated muscles are | | | |
| | able to improve or | | | |
| | facilitate muscle | | | |
| | performance. The miha | | | |
| | bodytec II may | | | |
| | therefore be considered | | | |
| | a technique of muscle | | | |
| | training | | | |

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| Connection of the device to electrodes | One stimulation module / control unit which is channel-wise connected to the i-body® electrodes over a cable to the i-body® vest. The electrodes of the i-body® straps and belt are connected via cables to the vest. | One stimulation module / control unit which is channel-wise connected to the i-body® electrodes over a cable to the i-body® vest. The electrodes of the i-body® straps and belt are connected via cables to the vest. | One stimulation module / control unit which is channel-wise connected to the respective electrodes | Similar electrode connection from a control unit to the attached electrodes |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source(s) | Control unit: 15 V - 19 V; External power supply (100 - 240 V ~ 50 - 60 Hz) | Control unit: 15 V - 19 V; External power supply (100 - 240 V ~ 50 - 60 Hz) | 4.8 V (2000 mAh) NiMH rechargeable battery | No difference between subject and primary predicate device.<br>Difference between subject and secondary predicate device. The external power supply of subject device was tested according to AAMI/ANSI ES 60601-1:2005/(R) 2012 and A1:2012. No new concerns regarding safety and effectivene ss were raised during verification |
| | | | | and<br>validation. |
| - Method of<br>Line Current<br>Isolation | Power Supply in<br>accordance with IEC<br>60601-1 | Power Supply in<br>accordance with IEC<br>60601-1 | N/A (battery<br>operated device) | No<br>difference<br>between<br>subject and<br>primary<br>predicate<br>device.<br>Difference<br>between<br>subject and<br>secondary<br>predicate<br>device. See<br>comment<br>on power<br>source. |
| - Patient<br>Leakage<br>Current | < 100 μΑ | < 100 μΑ | N/A (battery<br>operated device) | No<br>difference<br>between<br>subject and<br>primary<br>predicate<br>device.<br>Difference<br>between<br>subject and<br>secondary<br>predicate<br>device. See<br>comment<br>on power<br>source. |
| - Normal<br>condition | < 100 μΑ | < 100 μΑ | N/A (battery<br>operated device) | No<br>difference<br>between<br>subject and<br>primary<br>predicate<br>device.<br>Difference<br>between<br>subject and<br>secondary<br>predicate<br>device. See<br>comment<br>on power<br>source. |
| | | | | subject and<br>secondary<br>predicate<br>device. See<br>comment<br>on power<br>source.…