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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg) and lower back due to strain from exercise or normal household and work activities.

The 5000Z/Firefly is a portable, single channel TENS device with two pre-programmed operational modes. It is powered by 2 standard AAA alkaline or rechargeable batteries. All operational modes produce the Prizm Medical Bi-Sourced waveform. The user selects a pre-programmed mode by using the program buttons to select one of two program options. The user is able to adjust the intensity up or down. The 5000Z/Firefly is intended for Over-the-Counter sale. The 5000Z/Firefly battery icon on the LED will flash when the batteries need replacement.

The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs). "To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities."

The 5000Z System (OTC) is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for pain. It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the 5000Z Stimulator can be found in Exhibit E. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting, with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked intensity buttons.

Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

The Prizm Medical Inc.'s Thera-Cream™ product is used prior to electrode placement to reduce the impedance (resistance to alternating current), which increases the skin conductivity during electrotherapy treatment. Electrotherapy treatment includes the use of TENS (Transcutaneous Electrical Nerve Stimulators) and NMES (Neuromuscular Electrical Stimulators).

The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems. The Prizm Medical, Inc. Micro-Z™ Stimulation System is also used for Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. These uses were previously cleared under K951727.

Prizm Medical, Inc. Micro-Z™ Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the Micro-ZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro® strip that attaches the device to the Velcro® arm/leg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons.

The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.

The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.