(117 days)
The Tyece OTC EMS System, Model EM35 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered muscle stimulator. It does not contain information about acceptance criteria, study details, or device performance as typically found in a clinical study report or a detailed summary of safety and effectiveness. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study proving device performance.
The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It also includes the indications for use for the device.
§ 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).