(267 days)
Not Found
No
The description focuses on standard electrical muscle stimulation technology and programmable parameters, with no mention of adaptive learning, data analysis for personalized training, or any other AI/ML characteristics.
No
The intended use explicitly states that the device is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and "not for rehabilitation purposes."
No
The documentation states that the device is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and is for "stimulating healthy muscles in order to improve or facilitate muscle performance," indicating it's for training and performance enhancement rather than diagnosis.
No
The device description explicitly states it consists of a control unit, electrode vest, straps, and belt, all connected via cables. This indicates significant hardware components beyond just software.
Based on the provided information, the miha bodytec II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for stimulating healthy muscles to improve or facilitate muscle performance as an addition to other sports and for training muscles. It is explicitly not for rehabilitation, therapy, or treatment of medical diseases or conditions.
- Mechanism of Action: The device works by applying electrical impulses transcutaneously to stimulate motor nerves and cause muscle contractions. This is a physical interaction with the body, not an analysis of biological samples.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The miha bodytec II does not perform any such examination of biological samples.
The miha bodytec II is a powered muscle stimulator intended for fitness and performance enhancement in healthy individuals.
N/A
Intended Use / 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. It must be used for healthy muscles and clients, not be used for rehabilitation purposes.
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 therapy or treatment of medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.
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.
The various types of muscle work that the miha bodytec II can impose on the stimulated muscles are able to improve or facilitate muscle performance. The miha bodytec II may therefore a technique of muscle training.
Product codes (comma separated list FDA assigned to the subject device)
NGX
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 intensity, 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 sport setting. The device must be operated by a trainer who has received a full training from the manufacturer. Before the trainer selects the accessories incl. electrodes in the correct size, applies the athlete 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 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.
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 sport setting. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biocompatibility testing: Skin contacting material was tested to ISO 10993-5:2009 and ISO 10993-10:2009.
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 abdomenelectrode (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 F 1980-16. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2019
miha bodytec GmbH % Rhonda Alexander Sr. Consultant, Leadership & Regulatory Development IUVO Consulting, LLC P.O. Box 56483 Virginia Beach, Virginia 23456
Re: K182519
Trade/Device Name: miha bodytec II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 3, 2019 Received: May 6, 2019
Dear Rhonda Alexander:
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 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.
for Vivek Pinto Assistant Director, Acute Injury 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) K182519
Device Name miha bodytec II
Indications for Use (Describe)
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.
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 therapy or treatment of medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.
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.
The various types of muscle work that the miha bodytec II can impose on the stimulated muscles are able to improve or facilitate muscle performance. The miha bodytec II may therefore a technique of muscle training.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
1 Sponsor
| Sponsor: | miha bodytec GmbH
Siemensstr. 1
86368 Gersthofen
Germany |
|-----------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Rhonda Alexander
IUVO Consulting, LLC
(757) 582-4337
ralexander@iuvoconsulting.com |
Date Prepared: May 2, 2019
2 Device Name and Classification
Proprietary Name: miha bodytec II
Common/Usual Name: Powered muscle stimulator
Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning (21 CFR 890.5850, Product Code NGX)
Predicate Device 3
E-Fit EF-1280, K133225 Predicate Device:
Intended Use 4
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.
4
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 therapy or treatment of medical diseases or medical conditions of any kind. None of the miha bodytec II training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated.
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.
The various types of muscle work that the miha bodytec II can 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.
5 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 intensity, 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 sport setting. The device must be operated by a trainer who has received a full training from the manufacturer. Before the trainer selects the accessories incl. electrodes in the correct size, applies the athlete 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 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.
5
During pulse application, the trainer instructs the athlete on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button.
Predicate Device Comparison б
6.1 General
| Characteristic | New Device | Predicate Device | Similar / Different |
|---|---|---|---|
| 510(k) Number | K182519 | K133225 | - |
| Device Name, | |||
| Model | miha bodytec II | E-Fit EF-1280 | - |
| Manufacturer | miha bodytec GmbH | Fit-Pro KFT Ltd. | - |
| 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. It must be used for | |||
| healthy muscles and clients, | |||
| not be used for | |||
| rehabilitation purposes. | E-fit EF-1280 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 only healthy | |||
| muscles and clients, | |||
| not for rehabilitation | |||
| purposes. | There are no differences | ||
| between the subject | |||
| device and the | |||
| predicate(s) with respect | |||
| to indications and | |||
| intended use. | |||
| 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 therapy | |||
| or treatment of medical | |||
| diseases or medical | |||
| conditions of any kind. None | |||
| of the miha bodytec II | |||
| training programs are | |||
| designed for injured or ailing | |||
| muscles and its use on such | |||
| muscles is contraindicated. | The E-Fit EF-1280 | ||
| intended to stimulate | |||
| healthy muscles in | |||
| order to improve or | |||
| facilitate muscle | |||
| performance. The E- | |||
| Fit EF-1280 is not | |||
| intended to be used | |||
| in conjunction with | |||
| therapy or treatment | |||
| of medical diseases or | |||
| medical conditions of | |||
| any kind. None of the | |||
| E-Fit EF-1280 training | |||
| programs is designed | |||
| for injured or ailing | |||
| muscles and its use | - | ||
| The miha bodytec II | on such muscles is | ||
| electrical impulses allow the | contraindicated. | ||
| triggering of action | |||
| potentials on motoneurons | |||
| of motor nerves | The E-Fit EF-1280 | ||
| (excitations). These | electrical impulses | ||
| excitations of motoneurons | allow the triggering of | ||
| are transmitted to the | action potentials on | ||
| muscle fibers via the motor | motoneurones of | ||
| endplate where they | motor nerves | ||
| generate mechanical muscle | (excitations). These | ||
| fiber responses that | excitations of | ||
| correspond to muscle work. | motoneurones are | ||
| Depending on the | transmitted to the | ||
| parameters of the electrical | muscle fibers via the | ||
| impulses (pulse frequency, | motor endplate | ||
| duration of contraction, | where they generate | ||
| duration of rest, total | mechanical muscle | ||
| session duration), different | fiber responses that | ||
| types of muscle work can be | correspond to muscle | ||
| imposed on the stimulated | work. Depending on | ||
| muscles. | the parameters of the | ||
| electrical impulses | |||
| (pulse frequency, | |||
| duration of | |||
| contraction, duration | |||
| of rest, total session | |||
| The various types of muscle | duration), different | ||
| work that the miha bodytec | types of muscle work | ||
| II can impose on the | can be imposed on | ||
| stimulated muscles are able | the stimulated | ||
| to improve or facilitate | muscles. | ||
| muscle performance. The | |||
| miha bodytec II may | |||
| therefore be considered a | The various types of | ||
| technique of muscle | muscle work that the | ||
| training. | E-Fit EF-1280 can | ||
| impose on the | |||
| stimulated muscles | |||
| are able to improve or | |||
| facilitate muscle | |||
| performance. The E- | |||
| Fit EF-1280 may | |||
| therefore be | |||
| considered a | |||
| technique of muscle | |||
| training. | |||
| 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 / main unit | |||
| which is channel-wise | |||
| connected to the EF- | |||
| jacket and EF-shorts. | Similar electrode | ||
| connection from a | |||
| control unit to the | |||
| electrodes | |||
| Power | |||
| Source(s) | Control unit: 15 V - 19 V; | ||
| External power supply (100 |
- 240 V ~ 50 - 60 Hz) | 12V (3,4Ah) lead Acid
battery | Different. 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 effectiveness were
raised during verification
and validation. |
| - Method of
Line Current
Isolation | Power Supply in accordance
with IEC 60601-1 | N/A (battery operated
device) | Different. See comment
on power source. |
| - Patient
Leakage
Current |