(348 days)
Not Found
No
The summary describes a standard electrical muscle stimulation (EMS) device controlled by an app. There is no mention of AI or ML in the intended use, device description, or performance studies. The software is described as a simple visual interface for controlling the device.
No
The device is explicitly stated as "not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind" and "definitely not suitable for rehabilitation and physiotherapy," and it is "designed and manufactured for sports and fitness activity."
No
The FLIX-EMS device is clearly stated as "not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind" and its "use on such muscles is contraindicated." It is designed for muscle performance improvement in healthy individuals, not for diagnosis or detection of medical conditions.
No
The device description explicitly states it consists of an app (software), an electronic device (hardware), a Bluetooth transmission system (hardware), a suit with cables (hardware), and electrodes (hardware). It is not solely software.
Based on the provided information, the FLIX-EMS device is not an IVD (In Vitro Diagnostic) 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 in adults. It explicitly states it is not intended for adjunctive therapy in the treatment of medical diseases or conditions, and its use on injured or diseased muscles is contraindicated.
- Device Description: The description focuses on the mechanism of electrical muscle stimulation for fitness and training purposes. It describes the hardware (app, electronic device, suit, electrodes) and software used to deliver and control the electrical impulses for muscle contraction.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. IVD devices are specifically designed for these purposes.
- Target User and Setting: The intended user is specialized trainers in athletic training facilities, not healthcare professionals in a clinical setting for diagnostic purposes.
In summary, the FLIX-EMS device is a muscle stimulator intended for fitness and performance enhancement in healthy individuals, which falls outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy.
FLIX-EMS electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to 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.
Product codes
NGX
Device Description
The proposed device is an electro-medical device designed and manufactured for sports and fitness activity with low-intensity electro-stimulation technology. It is intended for stimulating healthy muscles in order to improve or facilitate muscle performance in training procedures with numerous special features.
When used as indicated, FLIX-EMS device is intended for muscle electro-stimulation. Low-intensity electro-stimulation simulates how our central nervous system activates muscle movement. Muscles move thanks to nerve impulses from the brain. These electrical stimuli are passed along nerves to the muscles, where they generate muscle contractions. Low-intensity electro-stimulation uses the same system to encourage muscle training.
The various muscle groups are stimulated using electrodes strategically positioned around the body to generate muscle contractions. The training dynamic combines voluntary movements by the user with muscle contractions generated by the low-intensity electro-stimulation, meaning that the muscle receives more effective stimulation and, in short, a more complete workout.
The electrodes cover most muscle groups and these are activated simultaneously so that the user can train various muscle groups at the same time. The user can train biceps and triceps at the same time, for example, which cannot be done with conventional weight training.
The device consists of an app (dashboard) that enables operating variables to be selected and monitored, an electronic device that controls the selected power supply and a Bluetooth data transmission system.
The suit contains a set of cables that carry the current via an emission system (electrodes) and is connected to the main unit via a master cable.
The FLIX-EMS app enables very simple and convenient operation of all the system software (program). The app is used by physically touching the screen on the terminal in which the app is installed, whether a smartphone, tablet or PC:
The software is a computer program that uses images and graphics to represent the available information and options. Its main purpose is to provide a simple visual interface for enabling communication with the device's operating system.
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
Adults only.
Intended User / Care Setting
Intended User: Only specialized trainers and certified in the sporting use of EMS.
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)
The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- 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 FLIX-EMS device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.
The new device is designed and manufactured in accordance with the following recognized standards:
- ANSI AAMI 60601-1:2005/(R)2012 And A1:2012 ●
- IEC 60601-1-2:2007
- 60601-2-10 Edition 2.1 2016-04 ●
- IEC 60601-1-6 Edition 3.1 2013-10 ●
- ISO 14971 Second Edition 2007-03-01 ●
- EN ISO 13485:2003 +/AC2009 ●
- IEC 62304:2006
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
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.
E-Fit EF-1280 (K133225), Compex Wireless USA (K170903)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
May 14, 2019
Casgarum Investment, S.L. Rafael Castillo General Manager Calle Real, 17 Bº E 45200, Illescas Toledo. Spain
Re: K181419
Trade/Device Name: FLIX-EMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 12, 2018 Received: October 1, 2018
Dear Rafael Castillo:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek Pinto, PhD Assistant Director, Acute Injury Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K181419
Device Name FLIX-EMS
Indications for Use (Describe)
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy.
FLIX-EMS electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to 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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information, Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Premarket Notification
SECTION 05 - 510(k) Summary
| DATE OF SUBMISSION:
SUBMITTER NAME:
SUBMITTER ADDRESS: | 2018-04-19
CASGARUM INVESTMENT, S.L.
Calle Real, 17 B E
45200, Illescas
Toledo, Spain |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT:
TELEPHONE: | Rafael Castillo
+34 925 51 26 67 |
| e-mail: | rcasgarum@gmail.com |
| DEVICE TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME: | FLIX-EMS
STIMULATOR, MUSCLE, POWERED
Stimulator, muscle, powered, for muscle conditioning
(21 CFR 890.5850) |
| PREDICATE DEVICE(S): | E-Fit EF-1280 (K133225)
Compex Wireless USA (K170903) |
DEVICE DESCRIPTION:
The proposed device is an electro-medical device designed and manufactured for sports and fitness activity with low-intensity electro-stimulation technology. It is intended for stimulating healthy muscles in order to improve or facilitate muscle performance in training procedures with numerous special features.
When used as indicated, FLIX-EMS device is intended for muscle electro-stimulation. Low-intensity electro-stimulation simulates how our central nervous system activates muscle movement. Muscles move thanks to nerve impulses from the brain. These electrical stimuli are passed along nerves to the muscles, where they generate muscle contractions. Low-intensity electro-stimulation uses the same system to encourage muscle training.
The various muscle groups are stimulated using electrodes strategically positioned around the body to generate muscle contractions. The training dynamic combines voluntary movements by the user with muscle contractions generated by the low-intensity electro-stimulation, meaning that the muscle receives more effective stimulation and, in short, a more complete workout.
The electrodes cover most muscle groups and these are activated simultaneously so that the user can train various muscle groups at the same time. The user can train biceps and triceps at the same time, for example, which cannot be done with conventional weight training.
4
510(k) Premarket Notification
SECTION 05 - 510(k) Summary
The device consists of an app (dashboard) that enables operating variables to be selected and monitored, an electronic device that controls the selected power supply and a Bluetooth data transmission system.
The suit contains a set of cables that carry the current via an emission system (electrodes) and is connected to the main unit via a master cable.
The FLIX-EMS app enables very simple and convenient operation of all the system software (program). The app is used by physically touching the screen on the terminal in which the app is installed, whether a smartphone, tablet or PC:
The software is a computer program that uses images and graphics to represent the available information and options. Its main purpose is to provide a simple visual interface for enabling communication with the device's operating system.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the FLIX-EMS device is compared with the following previously cleared devices:
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||||
|---|---|---|---|---|
| Characteristic / Feature | PROPOSED DEVICE | |||
| FLIX-EMS | PREDICATE DEVICE | |||
| E-Fit EF-1280 | PREDICATE DEVICE | |||
| Compex Wireless USA | Comparison | |||
| GENERAL COMPARISON | ||||
| Classification name | Powered muscle | |||
| stimulator | Powered muscle | |||
| stimulator | Powered muscle | |||
| stimulator | Same | |||
| Product code | NGX | NGX | NGX | Same |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical Medicine | Physical Medicine | Physical Medicine | Same |
| Class | Class II | Class II | Class II | Same |
| 510(K) Number | -- | K133225 | K170903 | N/A |
| INTENDED USE | ||||
| Intended use | FLIX-EMS device is | |||
| intended to stimulate | ||||
| healthy muscles in order | ||||
| to improve or facilitate | ||||
| muscle performance. It | ||||
| is to be used by adults | ||||
| only. |
FLIX-EMS is not | 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 | The Compex Wireless
USA 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. | Same
FLIX-EMS does not
include TENS |
| Characteristic / Feature | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | Comparison |
| | PROPOSED DEVICE
FLIX-EMS | PREDICATE DEVICE
E-Fit EF-1280 | PREDICATE DEVICE
Compex Wireless USA | |
| | intended for adjunctive
therapy in the treatment
of medical diseases and
conditions of any kind.
None of the FLIX-EMS
stimulation programs
are designed for injured
or disease afflicted
muscles. Its use on
such muscles is
contraindicated. The
work imposed on the
muscles by the FLIX-
EMS programs is
definitely not suitable for
rehabilitation and
physiotherapy.
FLIX-EMS 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
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 | muscles. It must be
used for only healthy
muscles and clients,
not for rehabilitation
purposes.
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
on such muscles is
contraindicated.
The E-Fit EF-1280
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
mechanical muscle
fiber responses that
correspond to muscle
work. Depending on
the parameters of
the electrical
impulses (pulse
frequency, duration
of contraction. | The Compex Wireless USA
is not intended for
adjunctive therapy in the
treatment of medical
diseases and conditions of
any kind. None of the
Compex Wireless USA
stimulation programs are
designed for injured or
disease afflicted muscles. Its
use on such muscles is
contraindicated. The work
imposed on the muscles by
the Compex Wireless USA
programs is definitely not
suitable for rehabilitation
and physiotherapy.
The Compex Wireless
USA 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
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
Compex Wireless USA may
therefore be considered a
technique of muscle training.
The Compex Wireless
USA TENS is used for:
• temporary relief of pain | |
| | | frequency, duration
of contraction,
duration of rest, total | | |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | | Session duration), different
types of muscle work can
be imposed 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. | associated with sore and
aching muscles due to
strain from exercise or
normal household and
work activities.
• the symptomatic relief
and management of
chronic, intractable pain
and relief of pain
associated with arthritis. | |
| Indications for use | To be used by adults
only. Must be used for
only healthy muscles
and clients. It is not
intended to be used in
conjunction with therapy
or treatment of medical
diseases or medical
conditions of any kind.
It is designed to be used
together with the Flix-
ems application for
tablets. | To be used by adults
only. 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. | To be used by adults
only. 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. | Similar
(Difference is the
software application
which controls the
device) |
| Prescription/OTC | Prescription use | Prescription use | Over-the-counter | Same as E-fit.
Different than
Compex |
| Use environment | Use in athletic training
facilities. Not for use
outdoors | Use in athletic training
facilities | Use in athletic training
facilities. Outdoor use
not restricted | Similar as E-fit and
Compex.
FLIX-EMS only for
indoor use |
| Anatomical sites | Electrodes can be
applied to multiple
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 | YES | Same |
| Power Source - battery | 8.4V(3400mA). Two
cells Lithium-ion | 12V - 3,4AH | Remote: Lithium
Polymer (LiPo)
rechargeable 3.7[V] /
$\ge$ 1500[mAh
Stimulation
Modules: Lithium
Polymer (LiPo)
rechargeable 3.7[V] /
$\ge$ 450[mAh] | Similar
FLIX-EMS, is fully
portable, the
battery needs to be
Li-ion battery,
which is similar to
Compex battery |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | |
| Characteristic / Feature | PROPOSED DEVICE
FLIX-EMS | PREDICATE DEVICE
E-Fit EF-1280 | PREDICATE DEVICE
Compex Wireless USA | Comparison |
| Battery operated | YES | YES | YES | Same |
| Regulated current and/or
voltage | YES, current | YES, current | YES, current | Same as Efit
Same as Compex
Wireless USA
Similar to Efit |
| Current / Voltage | 70mA/100V | 72mA/36V | 100mA/135V | Similar to Compex
Wireless USA
Similar to Efit |
| Plastic Housing
Materials | PLASTIC | STAINLESS STEEL | PLASTIC | Different than Efit
Similar to Compex |
| Maximum Output Voltage
(V)
(+/- 10%) | Toning 1:
35V @ $500Ω$
100V@ $2kΩ$
100V@ $10kΩ$
Toning 2:
35V
100V@ $2kΩ$
100V@ $10kΩ$
Training 1:
35V @ $500Ω$
100V@ $2kΩ$
100V@ $10kΩ$
Training 2:
35V
100V@ $2kΩ$
100V@ $10kΩ$
Training 3:
35V @ $500Ω$
100V@ $2kΩ$
100V@ $10kΩ$
Training 4:
35V
100V@ $2kΩ$
100V@ $10kΩ$
Customisable programs:
35V @ $500Ω$
100V@ $2kΩ$
100V@ $10kΩ$ | 36 V @ $500 Ω$ | Endurance:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Resistance:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Strength:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Explosive Strength:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Potentiation:
60 V @ $500 Ω$
152 V @ $2 kΩ$
132 V @ $10 kΩ$
Training Recovery:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Competition Recovery:
60 V @ $500 Ω$
165 V @ $2 kΩ$
165 V @ $10 kΩ$
Pre Warmup | Similar to Efit
(@ $500 Ω$ : Toning 1,
Toning 2, Training
1, Training 2,
Training 3 and
Training 4)
Similar to Compex
Wireless USA
(Maximum output
voltage is higher for
Compex Wireless
in all training
programs)
Flix-EMS has
limited output
voltage to 100 V |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | | | 60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ
Muscle Relaxation:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ
Pain Relief TENS:
180 [V] peak on 10[kΩ]
170 [V] peak on 2 [kΩ]
58 [V] peak on 500 [kΩ] | |
| | Toninig 1:
70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ
Toning 2: | 72 mA @ 500 Ω | Endurance:
116 mA @ 500 Ω
80 mA @ 2 kΩ
15 mA @ 10 kΩ
Resistance:
116 mA @ 500 Ω | Similar to Efit
(@500 Ω: Toning 1,
Toning 2, Training
1, Training 2,
Training 3 and
Training 4) |
| | 70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ | | 80 mA @ 2 kΩ
17 mA @ 10 kΩ
Strength:
113 mA @ 500 Ω | Similar to Compex
Wireless USA
(Maximum output
current is higher for
Compex Wireless |
| Maximum Output Current
(mA)
(+/- 10%) | Training 1:
70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ | | 80 mA @ 2 kΩ
15 mA @ 10 kΩ
Explosive Strength: | in all training
programs) |
| | Training 2:
70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ | | 81 mA @ 500 Ω
81 mA @ 2 kΩ
15 mA @ 10 kΩ | |
| | Training 3:
70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ | | Potentiation:
117 mA @ 500 Ω
80 mA @ 2 kΩ
16 mA @ 10 kΩ | |
| | Training 4:
70 mA @500Ω
50 mA @ 2kΩ
10 mA @ 10kΩ | | Training Recovery:
116 mA @ 500 Ω
81mA @ 2 kΩ
16 mA @ 10 kΩ | |
| | Customisable programs:
70 mA @500Ω
50 mA @ 2kΩ | | Pre Warmup
116 mA @ 500 Ω
81 mA @ 2 kΩ
15 mA @ 10 kΩ | |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | 10 mA @ $10 kΩ$ | | Muscle Relaxation:
116 mA @ 500 Ω
81 mA @ 2 kΩ
16 mA @ 10 kΩ
Pain Relief TENS:
18[mA] peak @10[kΩ]
86[mA] peak@2[kΩ]
116[mA] peak@500[Ω] | |
| Maximum power density | 4.08
mW/cm²@500Ω
(Smallest electrode) | 6.3 mW/cm² @500Ω | 27.6 mW/cm² @ 500Ω | Similar to Efit
Different than
Compex Wireless
USA (Compex USA
features a much
higher value) |
| Maximum current
density | 1.45 mA/cm² @ 500Ω
(Smallest electrode) | 0.85 mA/cm² @ 500Ω | 4.8 mA/cm² @ 500Ω | Similar to Efit
Different than
Compex Wireless
USA (Compex USA
features a much
higher value) |
| Number of Output
channels
-Synchronous or
Alternating?
-Method of Channel
Isolation | 1 CHANNEL
1 output channel can
shift in time to the 10
outputs but electrical
current can be regulated
individually on every
outputs. | 1 CHANNEL
1 output channel can
shift in time to the 12
outputs but electrical
current can be
regulated individually on
every outputs | 4 CHANNELS
Synchronous with 2msec
delay between channels | Similar than E-fit
Different than
Compex Wireless
USA |
| Waveform (e.g., pulsed
monophasic, biphasic)
(program per program) | Symmetric Biphasic (all
programs) | Symmetric Biphasic (all
programs) | -Endurance:
Symmetrical Biphasic
-Resistance:
Symmetrical Biphasic
-Strength :
Symmetrical Biphasic
-Explosive Strength:
Symmetrical Biphasic
-Potentiation:
Symmetrical Biphasic
-Training Recovery
(same
as Active Recovery):
Symmetrical Biphasic
-Competition
Recovery (same as | Same as Efit (All
programs
'symmetric
biphasic' in both
cases)
Similar to Compex
Wireless USA (all
programs
'symmetric
biphasic' expect for
the 'Pain relief -
TENS' but
no TENS
included in
the
FLIX-EMS |
| Characteristic / Feature | PROPOSED DEVICE
FLIX-EMS | PREDICATE DEVICE
E-Fit EF-1280 | PREDICATE DEVICE
Compex Wireless USA | Comparison |
| Pulse width (μs) | 50-400(μs)
Toning 1:
350 (μs)
Toning 2:
350 (μs)
Training 1:
350 (μs)
Training 2:
150 (μs)
Training 3:
350 (μs)
Training 4:
400 (μs)
Customisable programs:
50-400(μs) | 100-500(μs) | Symmetrical Biphasic
-Pre-Warmup Program:
Symmetrical Biphasic
-Muscle Relaxation
(same
as Massage):
Symmetrical Biphasic
-Pain relief TENS (same
as FM): Balanced,
asymetrical Biphasic
Endurance:
200-400 (μs)
Resistance:
200-400 (μs)
Strength:
200-400 (μs)
Explosive strength:
200-400 (μs)
Potentiation
200-400 (μs)
Training recovery:
200-400 (μs)
Competition recovery:
200-400 (μs)
Pre warmup:
200-400 (μs)
Muscle relaxation:
200-400 (μs)
Pain Relief TENS: 70 to
300[µs] (measured at
50% of positive pulse) | Device)
Similar to Efit (all programs within the range of pulse of Efit except for the 'customisable')
Similar to Compex Wireless USA (all programs within the range of Compex except for the 'customisable') |
| Frequency | 5-100 Hz
Toning 1:
85 Hz
Toning 2:
90 Hz | 5-120 Hz | 0,5 to 122 Hz
Endurance:
10 Hz
Resistance:
50 Hz | Similar to Efit (all programs of FLIX-EMS within the frequency range of the Efit) |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | Training 1:
7 Hz | | Strength:
75 Hz | Similar to Compex
Wireless USA |
| | Training 2:
100 Hz | | Explosive strength:
100 Hz | (all programs of
FLIX-EMS within
the range of the
Compex) |
| | Training 3:
50 Hz | | Potentiation:
From 1 to 75 Hz | |
| | Training 4:
50 Hz | | Training recovery:
10 Hz | |
| | Customisable program:
5-100 HZ | | Competition recovery:
0,5 Hz | |
| | | | Pre warmup:
4 Hz | |
| | | | Muscle relaxation:
1 Hz | |
| | | | Pain Relief TENS:
5 to 122 Hz | |
| | | | | Same as Efit |
| Reusable pads | YES | YES | NO | Different than
Compex |
| Number of programs | 6 pre-set programs + 3
customizable programs | 5+5 | 22 programs | Similar to Efit
Different than
Compex Wireless
USA |
| Program duration | 25 min | Maximum 30min | Maximum 60 minutes | Similar to Efit
Different than
Compex |
| Electrode dimensions
(cm) | 12x8x0.1 cm
8x6x0.1 cm | Electrodes with pre-
defined (supplied with
the device) size and
correct position | 10x5 cm and 5x5 cm
self-adhesive pads (FDA
cleared) | Similar to Compex
Wireless USA |
| User interface | Application on tablet or
mobile with Android and
Bluetooth
communication. If the
communication fails, the
device has a protection
so as not to damage the
user. Through the
program the level of
each channel assigned
to each muscle is | The rotary encoder allows for a quick set-up and because of the push button capability, the program can be stopped immediately for every channel. There are large START/STOP and POWER off buttons to begin the program and for complete power | User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation programs. | Similar, the FLIX-
EMS is controlled
by a tablet by
Bluetooth but
similar usability
interface. |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | |
| Characteristic / Feature | PROPOSED DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | Comparison |
| | FLIX-EMS | E-Fit EF-1280 | Compex Wireless USA | |
| | regulated with its
specific name and the
parameters of each
program are selected
with their exact name
and a START / STOP
button that starts or
stops the process. | shutdown. Because
of the pictographs and
fixed electrodes in the
clothing, it is very easy
to set the appropriate
muscle groups. | | |
| Portability / Mobile Use | Full portable and
protected with silicone
sleeve | Portable with difficulty, it
is not an easy movable
device. | Portable (small size) | Similar to Compex
Different than E-fit |
| Operator | Only specialized trainers
and certified in the
sporting use of EMS | By
manufacture
recommendations,
the
only person who can
operate the device must
obtain
certifications
provided by the seller.
This person must
complete the
certification prior to use
on a patient. | Adults / trainers using
EMS for training | Similar to Efit
Similar to Compex |
| Menu / Settings | Only one level of menus,
with previous selection
of code coach and client
code | Simple one-level menu
system. | levels/sub-menus,
complex
menusystem | Similar to Efit
Similar to Compex |
| Plugs | Cables connect to the
electrodes with Ø1'8 mm
miniature banana.
Cables connect to the
stimulator device with
plastic 14 pin and 8 pin
connectors. | Cables connect to the
electrodes with snap
fastener and connect to
the machine with plastic
12pin waterproof ip68
connector. | Electrodes sticks to the
skin and the modules
slide along the electrode
snap until it 'clicks'. They
are not connected to the
machine. | Different than Efit
(cables connecting
to the electrodes)
Different than
Compex |
| Conductivity of the
electrodes | The subjects needs to
wear a cotton bodywear
and these bodywear
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 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. | Conductive gel for
electrotherapy is used in
conjuction with the
disposable electrodes for
conductivity | Similar to Efit
Different than
Compex |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | |
| Characteristic / Feature | PROPOSED DEVICE
FLIX-EMS | PREDICATE DEVICE
E-Fit EF-1280 | PREDICATE DEVICE
Compex Wireless USA | Comparison |
| | | conductive pads are
washable and
disinfectable. | | |
| Placement of the
electrodes | Appropriately pre-placed
in specific areas
according to muscle
anatomy. | Appropriately pre-
placed in specific areas
according to muscle
anatomy. | Self-adhesive on any
area of the body. | Similar to Efit
Different than
Compex |
| Display | Display is on an
android tablet (LCD
touchscreen) with
Bluetooth
communication. | LCD 2x40 character
LCD display with LED
backlight. | Small -sized LCD color
screen | Similar to Efit
Similar to Compex |
| Statistical functions | It records in the tablet
and then on the cloud
server the total hours
grouped by each client
code and trainer. | Statistical functions –
counting the hours of
operation | Not available | Similar to E-fit |
| LAB tests performed | ANSI AAMI 60601-1
IEC 60601-1-2:2007
IEC 60601-1-6:2010
IEC 60601-2-10:2012
FCC 47 CFR Part 15
IEC 62304:2006 | IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-11:2010
IEC 60601-2-10:2012 | IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-6:2013
IEC 60601-1-11:2010
IEC 60601-2-10:2012
IEC 62304:2006 | Similar to Efit
Similar to Compex
Wireless USA |
5
510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
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510(k) Premarket Notification
SECTION 05 - 510(k) Summary
INTENDED USE:
As established in the Indications for Use Statement:
14
510(k) Premarket Notification
SECTION 05 - 510(k) Summary
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy.
FLIX-EMS 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 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.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as a wireless electro muscle stimulation device for fitness.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- 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 FLIX-EMS device was tested to FCC requirements and found to comply with the requirements of 47 CFR Part 15 §15.107 and §15.109.
The new device is designed and manufactured in accordance with the following recognized standards:
- ANSI AAMI 60601-1:2005/(R)2012 And A1:2012 ●
- IEC 60601-1-2:2007
15
510(k) Premarket Notification
SECTION 05 - 510(k) Summary
- 60601-2-10 Edition 2.1 2016-04 ●
- IEC 60601-1-6 Edition 3.1 2013-10 ●
- ISO 14971 Second Edition 2007-03-01 ●
- EN ISO 13485:2003 +/AC2009 ●
- IEC 62304:2006
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
CONCLUSIONS:
We believe the intended use, the indications for use and principle of operation of FLIX-EMS are the same as the intended use, indications for use and performance of the predicate device.
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 the proposed and predicate devices is the same
- Intended use and indications/principle of operations of proposed device and predicate devices are the same.
-
- There are minimum differences in the technological characteristic/performance data of the proposed device and those of the predicate devices, all of them comply with IEC 60601 and applicable collateral and particular standards. Thus, the SE is not affected.
Based on the information provided in this premarket notification, CASGARUM INVESTMENT, S.L., concludes that FLIX-EMS is substantially equivalent to the predicate device with reqard to safety and effectiveness.
- There are minimum differences in the technological characteristic/performance data of the proposed device and those of the predicate devices, all of them comply with IEC 60601 and applicable collateral and particular standards. Thus, the SE is not affected.