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510(k) Data Aggregation
K Number
K181419Device Name
FLIX-EMS
Manufacturer
Date Cleared
2019-05-14
(348 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Casgarum Investment, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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
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.
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