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The Tyece OTC EMS System, Model EM37 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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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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The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.

The Tyece OTC TENS Device, Model SEM44 is a dual channel TENS device operated by DC 4.5V (3 AAA batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads. There are 12 selectable, pre-programmed output waveforms (modes) to choose from, blus 3 programmable modes. The two channels can be individually adjusted for intensity from 0 to 50. Running time can be selected from 5 to 100 minutes. All parameters (Menu, Program Number, Impulse intensity for channels, Jow battery, key-lock, frequency, pulse width and timer) are displayed on a full screen display. The only patient contacting components are the Electrode Pads. The patient contacting materials are FDA cleared under K132588.