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Indications for EMS use are: - Prevention or retardation of muscle disuse atrophy - Relaxation of muscle spasms - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or improving range of motion of extremities Indications for TENS use are: - Symptomatic relief and management of chronic, intractable pain, and - Adjunctive treatment for post-surgical and post-trauma acute pain

SWISSSTIM is a battery-powered device for transcutaneous nerve and neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The unit delivers synchronous, low voltage stimulation impulses at both of its outputs. The stimulation output voltage waveforms are in form of trains of monophasic, rectangular impulses. Such waveform character is true, when the outputs are connected to any resistor in a range from 100 Ω to 10,000 Ω. The EMS mode of this device has four different stimulation programs. The medical professional or patient under medical supervision can select any of these four stimulation programs, as appropriate for their treatment objectives. For each stimulation program, the medical professional or patient selects the desired phases of the stimulation programs as well as the stimulation duration; the impulse frequencies and impulse durations are different and all are preset at the factory. There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The user accessible controls are the ON/OFF button, the SELECT button and the two (2) buttons that control menu access and intensity levels for the 2 independent channels. The stimulus is a low voltage, low frequency, rectangular waveform. The TENS mode of this device has ten (10) programs. The TENS mode is what has been added to this device and therefore modifies the Indications for Use from the predicate device, K022175. The TENS mode is controlled in the same fashion as the EMS mode of the SWISSSTIM. The device is housed in a plastic enclosure and is powered by four (4) AAA batteries. Accessories include output cables, batteries, User's Manual, storage case and electrodes. There is no provision for an AC adapter and the unit cannot be connected to any AC electrical power circuit. From a technical perspective, the SWISSSTIM delivers stimulation pulses of 50v (peak value) ± 10% onto 500Ω at maximum settings, which corresponds to 100 mA (peak value) current intensity. The impulse frequencies produced by the device are in a range of 1 Hz to 120 Hz, depending on the choice of stimulation program. The voltage waveforms are rectangular monophasic with duration time from 20 us to 1000 us. The current impulses are monophasic on 500 Ω load. The tetanization stimulation signal includes ramp, which slowly increases the contraction intensity during treatments. The EMS function is used as a therapeutic tool, specifically for rehabilitation purposes as noted in the Indications for Use (please see Section B). An example is prevention of disuse muscle atrophy that may occur after musculoskeletal injuries such as damage to bones, joints, muscles, ligaments and tendons. The TENS functions address pain mitigation, whether chronic or acute pain; TENS is a non-invasive, safe nerve stimulation intended to reduce such pain. A number of systematic reviews or meta-analyses have confirmed TENS effectiveness for postoperative pain, osteoarthritis, and chronic musculoskeletal pain.