(137 days)
No
The summary describes a standard electrical muscle stimulation (EMS) device with various components and connectivity options. There is no mention of AI, ML, or any adaptive or learning algorithms used in the device's operation or program selection. The programs are pre-defined and parameters are adjusted by the trainer.
Yes
The device is intended to treat specific medical conditions, such as re-educating muscles, relaxation of muscle spasm, and retarding or preventing disuse muscle atrophy.
No
This device is intended to stimulate muscles for improvement or rehabilitation and does not perform any diagnostic functions like detecting, measuring, or analyzing physiological parameters to identify a medical condition.
No
The device description explicitly details hardware components including a control unit, electrode vest, straps, belt, and a wireless stimulation device ("i-body connect wireless") which contains a stimulation circuit board. While software is mentioned for control and updates, the device is fundamentally a hardware-based electrical muscle stimulator.
Based on the provided text, the miha bodytec II device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- miha bodytec II Function: The description clearly states that the miha bodytec II is a transcutaneous electrical muscle stimulation (EMS) device. It works by applying electrical impulses to the skin to stimulate muscles.
- Intended Use: The intended use is for muscle stimulation to improve performance, re-educate muscles, relax muscle spasms, and prevent disuse muscle atrophy. These are all related to the direct stimulation of the body, not the analysis of specimens taken from the body.
- Device Description: The description focuses on the hardware components (control unit, electrodes, vest, straps, belt) and how they deliver electrical stimulation. There is no mention of collecting or analyzing biological samples.
Therefore, the miha bodytec II falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
IPF, 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 duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles.
miha Bodytec II consists of a control unit mounted on a stand for the selection of programs, setting the parameters and starting/stopping the device, the i-body® electrode vest for applying electrodes to the upper body, i-body® straps for applying electrodes to the arm and legs and the i-body® belt for applying electrodes to the buttocks.
The device encompasses the following variants:
- "Miha bodytec II" control unit connected to the electrodes via cable
- "Miha bodytec II" control unit connected via Bluetooth through the "i-body connect wireless" device"
- "Miha bodytec m.ove" control unit for mobile use connected via Bluetooth through the "i-body connect wireless" device"
The "miha bodytec m.ove" is a lighter version of the "miha bodytec II" device. Almost all electrical components and circuit boards are identical. It shall mainly be used as a mobile solution either with "travel station m.ove" or with "work station m.ove" in medical facilities. It must be connected with the electrode system via the additional wireless stimulation equipment "i-body connect wireless" and has no cable connection.
The "travel station m.ove" is an equipment for the "miha bodytec m.ove" device (not for miha bodytec II) and is supposed to be used as a mobile solution for personal trainers all around the world. It will be used as a "bag" or "suitcase" where the device and the electrodes can be safely stored while travelling and will be used as a stand while the training with the customer is in progress. It has no electronics built in and is mainly made out of textiles, plastics and aluminum.
The "work station m.ove" is an additional equipment for the "miha bodytec m.ove" (not for miha bodytec II) and is supposed to be mainly used in hospitals, physiotherapy facilities and homes for the elderly. It will be used as a transport solution where the device and the electrodes can be safely stored while moving through the facilities and will be used as a stand while the training with the patient is in progress. It has no electronics built in and is mainly made out of wood, plastics and aluminum/steel.
The "i-body connect wireless" is a portable device, which is supposed to be worn at the patient's body. It has a built in stimulation circuit board and a Bluetooth receiver and produces the stimulation itself while the main device only acts as a remote control. This way a wireless training / treatment of the trainee / patient is possible. On the one hand, it is a mandatory equipment for the "miha bodytec m.ove" device due to the missing cable connection. On the other hand, it is an additional equipment for the "miha bodytec II" device, which can be used instead of the main connection cable. Through a corresponding software update, the second generation of the device (primary predicate device, K201975) can be changed into a third generation version (subject device, K221498), enabling the wireless functions of the device and thus compatibility with the i-body connect wireless.
miha bodytec II must be used in a professional setting incl. professional sport setting and stationary in closed rooms (clinics, hospitals, nursing homes, doctor's offices, physical therapists' private offices). The device must be operated by a trainer who has received a full training from the manufacturer. Before the training, the trainer selects the accessories in the correct size, applies the electrodes to the athlete/patient i.e. by wearing the electrode vest and connects the straps and belt via cable to the vest and via the "i-body connect wireless" device to the control unit. The trainer can choose between several training programs on the control unit for impulse familiarization basic/advanced, muscular endurance and body relax. The intensity can be adjusted by the trainer at the UI of the control unit separately for each channel. Complete body training which addresses all muscle groups is possible with up to 10 pairs of electrodes. Each athlete/patient receives an RFID transponder card for storing training results and individually adjusted programs. Once the training is started, the control unit generates and transmits the electrical signals wirelessly to the "i-body connect wireless" device and thus to the electrodes. miha bodytec II uses bipolar pulses and supplies all channels equally during all programs.
During pulse application, the trainer instructs the athlete/patient on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button.
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
above the age of 21.
Intended User / Care Setting
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 (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.
Bench testing of the electrodes was performed to demonstrate uniform current distributions (dispersion testing). The test case was built up according to FDA's requirements.
4 batches of electrodes were tested. From each batch 8 lateral back-electrodes, 1 upper back-electrode and 1 abdomen-electrode were selected. The electrodes were cut out of the vest and moistened to be covered by the undergarments. 8 measure points from each chest-electrode, each lateral back-electrode and each upper back-electrode as well as 5 measure points from each abdomenelectrode were defined. As indicated by FDA the electrodes were measured prior to and after cleansing. After this measuring period the accelerated aging was applied and followed by another measuring period which was conducted exactly the same like the first one. All tests successfully passed. To calculate the shelf life, we establish new testing according to ASTM F1980-16. In a climate cabinet an accelerating aging condition for the electrodes was simulated at 60°C for 10 weeks. Through testing the electrical resistance of the electrodes, a 3-year storage was tested. Altogether 10 electrodes and 6 contact points were tested. All tests were successfully passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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)
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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
+49 821 45 54 92 - 22 |
- Date Prepared: September 8, 2022
510(k) number: K221498
Device Name and Classification
- Proprietary Name: miha bodytec II
Common/Usual Name: Powered muscle stimulator
Classification Name: Stimulator, Muscle, Powered (21 CFR 890.5850, Product Code NGX and IPF)
Predicate Device
Predicate Device: Primary: miha bodytec II, K201975 Secondary: Katalyst Training System, K190966
Intended Use
miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles.
miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:
- Re-educating muscles
- Relaxation of muscle spasm
- Retarding or preventing disuse muscle atrophy
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 | |||||||
| 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 of contraction,
duration of rest, total
session duration), different
types of muscle work can
be imposed on the
stimulated muscles. | 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 ofmotoneurons
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 Katalyst Training
System is an Over-The-
Counter device intended
to stimulate healthy
muscles in order to
improve or facilitate
muscle performance. It
is to be used by adults
only.
The Katalyst Training
System is not intended
to be used in
conjunction with therapy
or treatment of medical
diseases or medical
conditions of any kind.
None of the training
programs or operational
parameters are
designed to target
injured or ailing muscles
and its use on such
muscles is
contraindicated. The
Katalyst Training
System's 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. | Similar between
subject and
primary
predicate
device.
Similar between
subject and
secondary
predicate
device in terms
of indications
for use related
to the product
code NGX. The
secondary
predicate
device does
not have listed
the IPF related
muscle
conditioning
indications. | | | | |
| Connection of
the device to
electrodes | | | | | | | |
| miha bodytec II (connection
via cable): 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.
miha bodytec II (connection
via i-body connect
wireless):
The body worn i-body | via i-body connect
wireless):
The body worn i-body
connect wireless is | 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. | | The Impulse Pack
connects to the Suit
through output cables
that terminate with pogo
pin connectors. The Suit
contains an embedded
cable harness which
makes connection with
the built-in electrodes.
Neither the cable
harness or the
electrodes are
removable. The Suit
also features leads with | electrodes are
removable. The Suit
also features leads with
snap connectors for | Similar between
miha bodytec II
(connection via
cable) and
primary
predicate
device.
Similar between
miha bodytec II
(connection via
i-body connect
wireless)/miha
bodytec m.ove | i-body connect
wireless)/miha
bodytec m.ove
and secondary |
7
| | controlled by the miha
bodytec II via Bluetooth and
connects to the i-body vest
through a short cable. The
electrodes of the i-body®
straps and belt are
connected via cables to the
vest.
miha bodytec m.ove:
The body worn i-body
connect wireless is
controlled by the miha
bodytec m.ove via
Bluetooth and connects to
the i-body vest through a
short cable. The electrodes
of the i-body® straps and
belt are connected via
cables to the vest. | connecting to the arm
electrodes | predicate
device. | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power
Source(s) | miha bodytec II:
Control unit: 15 V – 19 V;
External power supply (100
– 240 V ~ 50 – 60 Hz)
miha bodytec m.ove:
Lithium Ion (Li-Ion)
rechargeable battery
14.4V, 6900 mAh; Usage via
external power supply
possible as well (100 – 240
V ~ 50 – 60 Hz)
i-body connect wireless:
Lithium Ion (Li-Ion)
rechargeable battery
7.2V, 2900 mAh | Lithium Polymer (Li-Po)
rechargeable battery
7.4V, 2,050 mAh | No difference
between miha
bodytec II and
primay
predicate
device.
Difference
between
batteries of
miha bodytec
m.ove/i-body
conncect
wireless and
secondary
predicate
device due to
higher power. | |
| - Method of
Line Current
Isolation | miha bodytec II:
Power Supply in accordance
with IEC 60601-1
miha bodytec m.ove:
N/A (battery operated
device);
Usage with power supply:
Power Supply in
accordance with IEC
60601-1
i-body connect wireless:
N/A (battery operated
device) | N/A (battery operated
device) | Similar between
miha bodytec II
and primary
predicate
device.
Similar between
miha bodytec
m.ove/i-body
connect
wireless and
secondary
predicate
device. | |
| - Patient
Leakage
Current | miha bodytec II: