(296 days)
Not Found
No
The summary describes a standard electrical muscle stimulation (EMS) device and makes no mention of AI or ML technologies in its intended use, device description, or performance studies.
No
The device is explicitly stated as "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind" and "not for rehabilitation purposes," indicating it is not a therapeutic device.
No
The device description explicitly states that the I-MOTION is not intended for therapy or treatment of medical conditions, nor for injured or ailing muscles, but rather for stimulating healthy muscles to improve performance. This indicates a non-diagnostic purpose.
No
The device description explicitly states it is an "electro-medical device" and a "machine with electronic muscle stimulation based on EMS technology," indicating it includes hardware components for electrical stimulation.
Based on the provided text, the I-MOTION device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- I-MOTION's intended use: The text clearly states that the I-MOTION is intended to "stimulate healthy muscles in order to improve or facilitate muscle performance." It is used externally on the body and does not involve testing samples taken from the body.
- Lack of diagnostic claims: There are no mentions of the device being used for diagnosis, monitoring, or screening of any medical condition. Its purpose is purely for muscle stimulation for performance enhancement in healthy individuals.
Therefore, the I-MOTION device falls under the category of a physical medicine device, specifically an electronic muscle stimulator, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contra indicated.
I-MOTION 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.
I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate 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
Device Description
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Electrodes can be applied to multiple anatomical sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use in athletic training facilities. Not for use outdoors
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)
Functional laboratory tests conducted under foreseeable operating conditions showed proper operation of the device according to its intended use, including specifically:
- Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
- Electromagnetic compatibility -
- FCC Radio Frequency Testing The I-MOTION device was tested to FCC requirements and found to comply with the requirements of 47CFR Part15 n15.107 and n15.109.
The new device is designed and manufactured in accordance with the following standards:
- IEC 60601-1:2005 3rd edition .
- IEC 60601-1-2:2007
- IEC 60601-2-10:2012
- IEC 60601-1-6 Edition 3.1 2013-10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WIEMSpro (K181955)
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
May 26, 2022
I-Motion Group Global Iberica S.L. Jose Soto Belloso Managing Director Calle Loeches 66.8 CP Alcorcon, Madrid 28925 Spain
Re: K212413
Trade/Device Name: I-Motion, I-Motion Fit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 25, 2022 Received: April 26, 2022
Dear Jose Soto Belloso:
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,
for 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
2
Indications for Use
510(k) Number (if known) K212413
Device Name I-Motion I-Motion Fit
Indications for Use (Describe)
I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contra indicated.
I-MOTION 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.
I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. INFORMATION
| DATE OF SUBMISSION: | 2021-April-01 |
|---|---|
| SUBMITTER NAME: | I-MOTION GROUP GLOBAL IBERICA S.L. |
| SUBMITTER ADDRESS: | Calle Loeches 66.8 |
| 28925-Alcorcón, Madrid | |
| SPAIN | |
| CONTACT: | Jose Luis Soto Belloso |
| TELEPHONE: | +34 914 93 88 45 |
| e-mail: | jl.soto@i-motion.es |
| DEVICE TRADE NAME: | I-Motion, I-Motion Fit |
| COMMON NAME: | Powered muscle stimulator. |
| CLASSIFICATION NAME: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| (21 CFR 890.5850) | |
| PREDICATE DEVICE(S): | WIEMSpro (K181955) |
2. DEVICE DESCRIPTION
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights.
4
3. SUMMARY OF COMPARISON WITH PREDICATE DEVICE
In the establishment of substantial equivalence, the I-Motion device is compared with the following previously cleared devices:
- WiEMSpro (K181955)
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic | ||||
| / Feature | PROPOSED DEVICE | |||
| I-Motion | PREDICATE DEVICE | |||
| WIEMSpro | Comparison | |||
| GENERAL COMPARISON | ||||
| Classification | ||||
| name | Powered muscle stimulator | Powered muscle stimulator | Same | |
| Product code | NGX | NGX | Same | |
| Regulation | ||||
| number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same | |
| Panel | Physical Medicine | Physical Medicine | Same | |
| Class | Class II | Class II | Same | |
| 510(K) | ||||
| Number | -- | K181955 | N/A | |
| INTENDED USE | ||||
| Intended use | Must be used for only healthy | |||
| muscles and client. It is not intended | ||||
| to be used in conjunction with | ||||
| therapy or treatment of medical | ||||
| conditions of any kind. | Must be used for only healthy muscles | |||
| and client. It is not intended to be used | ||||
| in conjunction with therapy or treatment | ||||
| of medical diseases or medical | ||||
| conditions of any kind.. | Same | |||
| Indications | ||||
| for use | I-MOTION is intended to stimulate | |||
| healthy muscles in order to | ||||
| improve or facilitate muscle | ||||
| performance, is not intended to be | ||||
| used in conjunction with therapy or | ||||
| treatment of medical diseases or | ||||
| medical conditions of any kind. | ||||
| None of I-MOTION training | ||||
| programs is designed for injured or | ||||
| ailing muscles and its use on such | ||||
| muscles is contraindicated. | ||||
| Each of the I-MOTION training | ||||
| programs 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. | ||||
| I-MOTION is a machine with | ||||
| electronic muscle stimulation | ||||
| based on EMS technology. | ||||
| Regarding its use, I-MOTION is | ||||
| specifically designed as an | ||||
| addition to other sports and for | ||||
| training muscles. It must be used | WIEMSPRO is intended to stimulate | |||
| healthy muscles in order to improve or | ||||
| facilitate muscle performance. The | ||||
| WIEMSPRO is not intended to be used | ||||
| in conjunction with therapy or treatment | ||||
| of medical diseases or medical | ||||
| conditions of any kind. None of | ||||
| WIEMSPRO training programs is | ||||
| designed for injured or ailing muscles | ||||
| and its use on such muscles is | ||||
| contraindicated. | ||||
| WIEMSPRO 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. | ||||
| WIEMSPRO electrical impulses allow | ||||
| the triggering of action potentials on | ||||
| motoneurones of motor nerves | ||||
| (excitations). | ||||
| These excitations of motoneurones are | ||||
| transmitted to the muscle fibers via the | ||||
| motor endplate where they generate | Similar. | |||
| Difference is the | ||||
| Software application | ||||
| which controls the | ||||
| device, not affecting the | ||||
| safety, efficiency, or | ||||
| functionality of the | ||||
| device. | ||||
| I-MOTION GROUP | ||||
| GLOBAL IBERICA | 510(k) Premarket Notification | Image: i-motion logo | ||
| 510(k) SUMMARY | ||||
| rehabilitation purposes. | 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. | ||||
| Prescription/ | ||||
| Rx | Prescription only | Prescription only | Same | |
| Use | ||||
| environment | Use in athletic training facilities. Not | |||
| for use outdoors | Use in athletic training | |||
| facilities. Not for use | ||||
| outdoors | Same | |||
| Anatomical | ||||
| sites | Electrodes can be applied to | |||
| multiple anatomical sites. | Electrodes can be applied | |||
| to multiple anatomical | ||||
| sites. | Same | |||
| TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE | ||||
| Powered | ||||
| Muscle | ||||
| Stimulator | YES | YES | Same | |
| Power | ||||
| Source | Battery:2 x 3.7 V= 7,4V |
- 3,4AH (Lithium) | Battery:3.7V-2,4AH (LiPo) | Similar
Minimal differences in the
technical
characteristic/performance,
not affecting the safety,
efficiency, or functionality
of the device |
| I-MOTION GROUP
GLOBAL IBERICA | 510(k) Premarket Notification | | Image: imotion logo | |
| 510(k) SUMMARY | | | | |
| Method of line
current
isolation | N/A (battery operated device) | N/A (battery operated device) | Same | |
| Patient leakage
current
-Normal
condition
-Single fault
condition | N/A (battery operated device)
N/A (battery operated device) | N/A (battery operated device)
N/A (battery operated device) | Same | |
| Battery operated | YES, lithium polymer cell
rechargeable | YES, lithium polymer cell
rechargeable | Same | |
| Number of
Output modes | One output mode, but with varying
stimulation frequency and duty
cycle ranges | One output mode, but with
varying stimulation
frequency and duty cycle
ranges | Same | |
| Number of
Output channels - Synchronous or
Alternating?
-Method of Channel
Isolation | 1 CHANNEL
Alternating | 1 CHANNEL
Alternating | Same | |
| Independent
channels with
possibility to
regulate the
current
individually | 10 CHANNELS | 10 CHANNELS | Same | |
| Current /
Voltage | 90mA/45V | 125mA/62.5V | Similar
Minimal differences
in the technical
characteristic/perfor
mance, not affecting
the safety, efficiency, or
functionality of the
device. | |
| Regulated current
and/or voltage | Yes, regulated current | Yes, regulated current | Same | |
| Software/Firmwar
e/Microprocessor
Control? | Yes | Yes | Similar
Minimal differences
in the technical
characteristic/perfor
mance, not affecting
the safety, efficiency, or
functionality of the device. | |
| Automatic
Overload Trip? | Yes | Yes | Same | |
| Automatic No-
Load Trip? | Yes | Yes | same | |
| Automatic Shut
Off? | On/Off switch | On/Off switch | Same | |
| Patient Override
Control? | Yes, push on On/Off button directly
pause the program | Yes, push on On/Off
button directly pause the
program | Same | |
| Indicator
display | Yes | Yes | Same | |
| -On/Off status? | Yes | Yes | Same | |
| -Low Battery? | Yes | Yes | Same | |
| Voltage/Curre
nt level? | Yes | Yes | Same | |
| Pulse duration
(width) | 150-450 µsec | 100-400 µsec | Same | |
| Frequency | 1-100 Hz | 1-100 Hz | Same | |
| Time range
(minutes) | Maximum program: unlimited | Maximum program: unlimited | Same | |
| Plastic
Housing
Materials | PLASTIC | PLASTIC | Same | |
| Device Weight | 300 g | 300 g | Same | |
| Dimensions
(in.) [W x H x
D] | [5,3 x 2,7 x 1,7] in | [6,66 x 3,27 x 1,18] in | Similar | |
| Reusable Pads | Yes | Yes | Same | |
| Compliance
with voluntary
standards /
LAB tests
performed | IEC 60601-1:2005 (ed. 3.0) +
corrigendum 2006+ corrigendum
2007 + interpretation sheet 2008 +
interpretation sheet 2009 +
A1:2012
IEC 60601-1-6:2010 (ed.3.0) +
A1:2013
IEC 60601-1-2-10:2010 (ed.2.0) +
A1:2016
IEC 62304:2006
ISO 14971:2019 | IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006
ISO 14971:2007 | Similar
All the
corresponding
standard norms
are complied with,
the minimum
difference is due
to the updating of
the new versions
of the norms. | |
| Waveform
(e.g., pulsed
monophasic,
biphasic)
(program per
program) | Symmetrical biphasic (all programs) | Symmetrical biphasic (all
programs) | Same | |
| Maximum
output
voltage | 110V | 170V | Similar
Minimal differences in the
technical
characteristic/performanc
e, not affecting the safety,
efficiency, or functionality
of the device. | |
| Maximum
output
current | 90mA | 125mA | Similar
Minimal differences in the
technical
characteristic/performance,
not affecting the safety,
efficiency, or functionality of
the device. | |
| Maximum
power
density | 9 mW/cm²@500ohm | 9,61mW/cm²@500ohm | Similar
Minimal differences in the
technical
characteristic/performanc
e, not affecting the safety,
efficiency, or functionality
of the device. | |
| I-MOTION GROUP
GLOBAL IBERICA | 510(k) Premarket Notification | | | |
| | 510(k) SUMMARY | | | |
| Maximum
current
density | | 1.87mA/cm²
Smallest electrode size: 48cm² | 1.92mA/cm² Smallest electrode
size:65cm² | Similar
Minimal differences in the
technical
characteristic/performance, not affecting the safety,
efficiency, or functionality
of the device. |
| For
interferential
modes only:
Beat
Frequency
(Hz) | | N/A | N/A | N/A |
| For
multiphasic
waveforms
only:
Symmetrical
phases? | | N/A | N/A | N/A |
| Phase
Duration
(include units)
(state range, if
applicable)
(both phases,
if
asymmetrical) | | N/A | N/A | N/A |
| Net Charge
(µC per pulse)
(If zero, state
method of
achieving zero
net charge.) | | N/A | N/A | N/A |
| Maximum
Phase Charge,
(µC) | | N/A | N/A | N/A |
| Burst Mode
(i.e., pulse
trains) | | N/A | N/A | N/A |
| ON Time
(seconds) | | N/A | N/A | N/A |
| OFF Time
(seconds) | | N/A | N/A | N/A |
| Electrodes | | Silicone conductive electrodes;
reusable They never come into
direct contact with the skin, as | Conductive fabric,
reusable electrodes (not in
direct contact with skin) | Same |
| 510(k) SUMMARY | | | | |
| | cotton covers and garments are
used on the user's body.
9 pairs of electrodes, stimulating
only one muscle group at a time
Sizes: 96 cm2 and 48 cm2 | 9 electrode pairs and each
pair of electrodes moves
only one group of muscle
simultaneously.
Sizes:
65 cm2
83 cm2 | | |
| Connection
electrodes
with
stimulator/cabl
es | PIN 2 mm | Lead wires
Stainless steel snap
fastener | Similar
Minimal differences
in the technical
characteristic/perfor
mance, not affecting
the safety,
efficiency, or
functionality of the
device. | |
| Conductivity
médium | The subject needs to put
on an 100% hygroscopic
cotton underwear
(surgery textile,
biocompatibility certified)
and these underwear
needs to be
soaked/irrigated with
normal tap water. So the
electro conductive media
is simply tap watered
cotton which is in contact
with the electrodes. The
surface of the electrode
will not get dry. In this case the
pulse
transmission efficiency
will not decrease. The
small conductive pads are
washable and disinfectable. | The subject needs to put
on an 100% hygroscopic
cotton underwear
(surgery textile,
biocompatibility certified)
and these underwear
needs to be
soaked/irrigated with
normal tap water. So the
electro conductive media
is simply tap watered
cotton which is in contact
with the electrodes. The
surface of the electrode
will not get dry. In this
case the pulse
transmission efficiency
will not decrease. The
small conductive pads are
washable and
disinfectable. | Same | |
5
6
7
8
i-motion
9
10
I-MOTION GROUP GLOBAL IBERICA
510(k) Premarket Notification
i-motion
11
| I-MOTION GROUP
| GLOBAL IBERICA | 510(k) Premarket Notification | Image: i-motion logo |
|---|---|---|
| 510(k) SUMMARY |
None of the differences presented above impact the equivalence of the subject device when compared to the predicate devices.
12
4. INDICATIONS FOR USE
As established in the Indications for Use Statement:
I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.None of the I-MOTION training programsis designed for injured or ailing muscles and its use on such muscles is contraindicated.
II-MOTION 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.
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.
None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
5. SUMMARY DISCUSSION OF NON-CLINICAL DATA
The proposed device has been subject to be testing to determine conformance to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory tests conducted under foreseeable operating conditions showed proper operation of the device according to its intended use, including specifically:
- Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)
- Electromagnetic compatibility -
- FCC Radio Frequency Testing The I-MOTION device was tested to FCC requirements and found to comply with the requirements of 47CFR Part15 n15.107and n15.109.
The new device is designed and manufactured in accordance with the following standards:
- IEC 60601-1:2005 3rd edition .
- IEC 60601-1-2:2007
- IEC 60601-2-10:2012 ●
13
| I-MOTION GROUP
| GLOBAL IBERICA | 510(k) Premarket Notification | Image: i-motion logo |
|---|---|---|
| 510(k) SUMMARY |
- IEC 60601-1-6 Edition 3.1 2013-10
6. SUMMARY DISCUSSION OF CLINICAL DATA
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence.
7. CONCLUSIONS
We believe the intended use, the indications for use and principle of operation of I-MOTION are the same as the intended use, indications for use and performance of the predicate devices. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
-
- General information of both devices is the same
-
- Intended use and indications/principle of operations of both devices are the same.
-
- There are minimum differences in the technological characteristic/performance at a of the proposed device and those of the predicate devices, nevertheless, all of them comply with IEC60601-1-2, IEC60601-2-10. Thus, the SE is not affected.
Based on the information provided in this pre-market notification, concludes that I-MOTION is substantially equivalent to the predicate device regarding safety and effectiveness.