Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard electrical muscle stimulation (EMS) device with pre-set programs and adjustable parameters. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

Yes
The device is described as an electronic muscle stimulation machine with indications for "Re-educating muscles," "Relaxation of muscle spasm," and "Retarding or preventing disuse muscle atrophy," all of which are therapeutic applications. Additionally, the device's use in "clinics, hospitals, nursing homes, doctor's offices, physical therapists' private offices" reinforces its therapeutic intent.

Diagnostic

No

The device is an electrical muscle stimulation (EMS) machine intended to stimulate muscles for improvement or facilitation of muscle performance and for conditions like re-educating muscles, relaxation of muscle spasm, and retarding/preventing disuse muscle atrophy. It is not described as diagnosing any conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the miha bodytec II consists of a control unit, electrode vest, straps, and belt, which are all hardware components. The software mentioned is firmware that controls these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, the miha bodytec II is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The miha bodytec II is a transcutaneous electrical muscle stimulation (EMS) device that applies electrical impulses to the body's surface to stimulate muscles. It does not involve the analysis of any bodily specimens.
The Intended Use/Indications for Use clearly describe the device's purpose as muscle stimulation for training, re-education, relaxation of spasms, and preventing disuse atrophy. These are all related to the direct interaction with the body's muscular system, not the analysis of in vitro samples.
The Device Description details the components and how they deliver electrical impulses to the body. This aligns with an external stimulation device, not an IVD.
The performance studies described focus on electrical safety, software validation, usability, and electrode performance (dispersion and shelf life). These are typical tests for an electrical medical device that interacts with the body, not for an IVD which would involve analytical performance studies on biological samples.

In summary, the miha bodytec II is a therapeutic or rehabilitation device that works by applying electrical stimulation to the body, which is fundamentally different from the function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

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.

Product codes

NGX, IPF

Device Description

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

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

To calculate the shelf life, we establish new testing according to ASTM F1980-16. In a climate cabinet an accelerating aging condition for the electrodes was simulated at 60°C for 4 weeks. Through conducting a typical training current while being in the climate cabinet, a 1 year shelf life as well as a 1 year storage was tested. Altogether 72 electrodes were tested. All tests successfully passed.

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.

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.

Key Metrics

Not Found

Predicate Device(s)

K182519, K090632

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

March 11, 2021

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

Re: K201975

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

Dear Felix Schweigert:

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

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

1

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

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

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

Sincerely.

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

Enclosure

2

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

Device Name and Classification

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

Predicate Device

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

Intended Use

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

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

Re-educating muscles
Relaxation of muscle spasm

4

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
device | Secondary
Predicate Device | Similar /
Different |
|------------------|------------|-----------------------------|-------------------------------|------------------------|
| 510(k)
Number | K201975 | K182519 | K090632 | - |

General

5

| Device Name,

Model	miha bodytec II	miha bodytec II	Compex rehab	-
Manufacturer	miha bodytec GmbH	miha bodytec GmbH	Chattanoogah	-
Regulation
Number	890.5850	890.5850	890.5850	Similar.
Product code	NGX; IPF	NGX	IPF	Different.
The subject
device
combines
both
product
codes NGX
and IPF of
the
predicate
devices
within the
same
regulation
number.
Indications for
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 a
machine with electronic
muscle stimulation
based on EMS
technology. Regarding
its use, the device is
specifically designed as
an addition to other
sports and for training
muscles. It must be
used for healthy
muscles and clients, not
be used for
rehabilitation purposes.	The Compex®
Rehab is an
adjunctive
multifunction
electrotherapy
device with various
treatment modes
that allow for
neuromuscular
electrical
stimulation
(NMES). The
Compex® Rehab is
indicated for the
following
conditions:	Similar
between
subject and
primary
predicate
device in
terms of
indications
for use
NGX.
The
primary
predicate
device does
not cover
the IPF
related
	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 | miha bodytec II is
intended to stimulate
healthy muscles in
order to improve or
facilitate muscle
performance. miha
bodytec II is not
intended to be used in
conjunction with | - Re-educating
muscles | therapeutic
indications.
Similar
between
subject and
secondary
predicate
device in
terms of |
| | - Relaxation of muscle
spasm | therapy or treatment of
medical diseases or | - Relaxation of
muscle spasm | indications
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 | | | |

6

7

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