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510(k) Data Aggregation
K Number
K230261Device Name
Gnesis EMS Plus
Manufacturer
Date Cleared
2023-06-06
(126 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Creative Fitness Developments S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in coniunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology. Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
Device Description
Gnesis EMS Plus is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. It must be used only on healthy muscles and patients, it is not designed for rehabilitation purposes.
The device must be worn over the underwear provided by the system manufacturer, ensuring that the electrodes do not come into direct contact with the patient's skin.
Gnesis EMS Plus System cannot be used while the user is performing demanding tasks, such as jumping or lifting weights, any exercise must be approved by a qualified trainer.
Genesis EMS Plus System includes the stimulator device, EMS suit with integrated electrodes, electrode wiring, specific underwear, stimulator charger (Off-the-shelf USB-C PD 3.0) and control device (Off-the-shelf Android Tablet with custom application)
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