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510(k) Data Aggregation
K Number
K133225Device Name
E-FIT EF-1280 EMS MACHINE
Manufacturer
FIT-PRO KFT LTD.
Date Cleared
2014-10-24
(368 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
FIT-PRO KFT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
E-Fit EP-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding is use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy museles 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 alling 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 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, and fotal session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the E-Fit E-Fit E-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF-1280 may therefore be considered a technique of muscle training.
Device Description
E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
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