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The geko W-2 is indicated for: - Increasing local blood circulation - Edema reduction - Increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia while the device is active

The geko™ W-2 Neuromuscular Stimulator (geko™ W-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through choosing one of 10 stimulus settings. The geko™ W-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking. Each geko™ W-2 provides two 6 hour treatments with a 6 hour minimum rest period between treatments. Two optional accessories are available to hold the geko W-2 in place during treatment, if needed: a knee strap and an adhesive tape.

The firefly T-2 is intended for stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-2 is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind.

The firefly™ T-2 Neuromuscular Stimulator (firefly™ T-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating that provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The firefly™ T-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

- Increasing local blood circulation - Edema reduction

The geko™ W-2 neuromuscular stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through choosing one of 10 stimulus settings. The geko™ W-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking. Each geko™ W-2 provides two 6-hour treatments with a 6 hour minimum rest period between treatments. Two optional accessories are available to hold the geko W-2 in place during treatment, if needed: a knee strap and an adhesive tape.

- Increasing local blood circulation - Edema reduction - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis - Stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism

The geko™ T-2 and geko™ T-3 are single patient use, disposable (after 24 hours), fully integrated neuromuscular stimulator devices. Each model is composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The devices are applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The stimulus intensity varies with the pulse width, which can be set a follows depending on the device model: - geko™ T-2: 7 levels ranging from 50 usec to 400 µsec @ 27 mA - geko™ T-3: 11 levels ranging from 35 to 280 µsec @ 27 mA, 280 to 400 µsec @ . 38 mA, and 400 to 560 µsec at 54 mA The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz for all device models and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking. Both device models have the same principles of operation and the same indications for use. The choice of device model depends on the level of stimulation needed to achieve a visible contraction (twitch) of the patient's calf and dorsiflexion of the foot.

- Increasing local blood circulation - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis - Edema reduction

The geko™ T-3 Neuromuscular Stimulator (geko™ T-3) is single-patient use and disposable, with fully integrated electronics composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a molded plastic casing and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ T-3 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The stimulus intensity varies with the pulse width, which can be set to one of 11 levels: 35, 50, 70, 100, 140, 200 or 280 at 27 mA; 280 or 400 at 38 mA; and 400 or 560 at 54 mA. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking.

- Increasing local blood circulation - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

The geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulator devices were previously described in K152677 and K160299, respectively. There have been no changes to the design, technical specifications, or manufacturing of these devices since previously cleared. The devices are single patient use and disposable with fully integrated electronics composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The devices are applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2 (ranging from 50 µsec to 400 µsec) and one of eight levels for the geko™ Plus R-2 (ranging from 50 µsec to 560 µsec). The constant current output at each pulse width setting is nominally 27 mA for the geko™ T-2 and 54 mA for the geko™ Plus R-2. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz for both devices and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.

The geko(TM) Plus R-2 is intended for: - Increasing local blood circulation; and - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The geko™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ Plus R-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.

The geko™ T-2 Neuromuscular Stimulator is intended for: -Increasing local blood circulation; and -Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The geko™ T-2 Neuromuscular Stimulator (geko™ T-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through changes in the delivered pulse width. The geko™ T-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The stimulus intensity varies with the pulse width, which can be set to one of seven levels for the geko™ T-2. The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking. Electrical contact is made with the patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient contacting materials have been previously tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.

The geko™ T-1 Neuromuscular Stimulator is intended for: - Increasing local blood circulation, and - Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

The geko™ T-1 (geko™) Neuromuscular Stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The geko™ is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow.