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The P4-Fitness is intended for stimulation of healthy muscles in order to enhance and facilitate improved muscle performance. The P4-Fitness is therefore properly considered as a technique or method for muscle training. The P4-Fitness is NOT intended for use in any therapy or for the treatment of any medical conditions or diseases. The P4-Fitness training programs are not designed or intended for injured or otherwise impaired muscles and use of the P4-Fitness on such muscles is contraindicated.

The P4-FITNESS is a battery-powered device for transcutaneous neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The P4-FITNESS delivers low voltage stimulation impulses at both of its outputs synchronously. The stimulation output voltage waveforms are in form of trains of monophasic, rectangular, compensated impulses with a zero net current. Such waveform character is true, when the outputs are connected to any resistor in a range from 100 Ω to 10,000 Ω. The P4-FiTNESS device has six (6) different stimulation timing sequences. The users can select any of these stimulation programs, as appropriate for their objectives. For each stimulation program, the stimulation ON and OFF times, the impulse frequencies and impulse durations are different; all of these parameters are preset at the factory. There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The only user accessible controls are ON/OFF switches. intensity knobs (increase or decrease) and the Program Select switch. The stimulation impulses are low voltage, low frequency, rectangular in shape. The device is housed in a plastic enclosure and is powered by a 9-volt alkaline, non-rechargeable battery, Accessories include output cables, battery, electrode pads and User Manual. There is no provision for an AC adapter; the device can not be connected to any AC electrical power circuit. The device 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, with the frequency modulation patterns and timing thereof dependant on the choice of stimulation program. The waveform is rectangular, compensated monophasic with duration time from 40 us to 340 µs. The current impulses are also rectangular, monophasic and compensated, with zero net charge (no DC current) when measured on 500 chms load. The tetanization stimulation impulses include ramp modulation, which permits for gradual increase of the contraction intensity during training.

Electrical Muscle Stimulator (EMS) devices should only be used under advice from physician or a qualified health professional as adjunctive therapy for the treatment of medical conditions. The intended application is for stimulation of all parts of a body except head and frontal part of the neck. Specific applications include: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy; - Increasing local blood circulation; - Muscle re-education; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; - Maintaining or increasing range of motion of extremities.

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