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The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand. The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.

The BioniCare Hand System, Model BIO-2000 is portable, rechargeable, battery-operated, single Channel device that utilizes a voltage regulated output circuit to generate a spike-shaped Monophasic pulse with adjustable amplitude of 0 - 15 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator (BioniCare® Stimulator).

The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications: The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy . - Increases local blood circulation . - Muscle re-education • - Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Interferential Stimulation can be used in the following applications: - Symptomatic relief of post traumatic acute pain - . Symptomatic relief of chronic pain intractable pain - . Relaxation of muscle spasms - Maintaining or increasing range of motion - Increases local blood circulation Pulsed Direct Current stimulation can be used in the following applications: - Reduction of edema (under negative electrode) - Relaxation of muscle spasm - . Increasing local blood circulation - Retardation or prevention of disuse atrophy - Muscle re-education - Maintaining or increasing of range of motion

The T.E.A.R. Tech 3 IF/Muscle Stimulator is a device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device. The device produces a low electrical current that is transmitted via lead wires to electrodes placed on the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and keypad.

The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.

The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.

The TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain

The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.

The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below: - Relaxation of muscle spasms . - Prevention or retardation of disuse atrophy ● - Increases local blood circulation ● - . Promotes muscle re-education and range of motion - . Maintaining and increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis . Interferential Stimulators have one additional indication for use: - Provides symptomatic relief and management of post surgical, acute, or chronic . pain The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device combining the functionality of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators in one device which produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

This device is a 'combination' device and has the same indications for use as two different types of predicate devices. High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below. - Relaxation of muscle spasms ● - Prevention or retardation of disuse atrophy . - Increasing local blood circulation ● - Muscle re-education . - Maintaining or increasing range of motion ● - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ● Interferential Stimulators have one additional indication for use: Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.

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